Second Opportunities for Lasting Change

Dr. Moeller stands with his arms crossed in front of the VCU Medical Center Emergency Department entrance. He is wearing a white lab coat.
Wright Center Director F. Gerard Moeller, M.D., is the principal investigator on a clinical trial that is initiating long-term care for opioid overdose survivors inside emergency departments. Photo: Kevin Schindler

This story originally appeared in the MCV Foundation‘s Next magazine. To read the full story and other articles about life-changing innovations occurring on the MCV Campus, click here

Those who survive an opioid overdose usually do so because they’re found in varying states of consciousness by family members, friends, caregivers or first responders before their breathing stops completely.

These survivors gain an additional opportunity at life, but oftentimes, because of the nature of their illness, they can’t use their new opportunities for change and recovery.

F. Gerard “Gerry” Moeller, M.D., director of the VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research, began contemplating these missed opportunities one day in 2017 after hearing from colleagues in the VCU Health Emergency Department.

“They came to me and said they were seeing overdose patients time and time again, and they felt like they just weren’t accomplishing anything,” Dr. Moeller said. “They were reviving the patients, but then the survivors weren’t getting into long-term treatment.”

Dr. Moeller, who is internationally known for his translational research on impulsivity and addictions, is keenly aware of the importance long-term treatment plays in pulling people out of a deadly spiral like the one his colleagues described to him, and he wanted to help.

His preliminary data showed that opioid overdose visits to the VCU Health Emergency Department went from approximately 270 in 2015 to more than 650 in 2017, and from all of those visits, as many as one in five patients experienced a repeat overdose or died within 12 months of their initial overdose.

Dr. Moeller knew these numbers demanded action toward finding the reason survivors weren’t getting the help they needed, and, most importantly, toward identifying a new approach to helping the survivors avail the opportunities they’d been given for a new life.

Why are survivors not getting help?

After an overdose victim arrives at the emergency department, he or she is stabilized, monitored for some time and then referred to a long-term outpatient facility where appropriate follow-up treatment, usually for addiction, can begin.

Dr. Moeller believes this referral is the critical moment in the treatment paradigm that can and should be changed. That’s because the overdose medication naloxone is very effective at saving lives, but it also causes acute opioid withdrawal, leading to nausea, vomiting, sweating, diarrhea, chills, cravings, impulsivity and poor decision-making.

“One of the behavioral definitions of impulsivity is the lack of ability to delay your gratification,” Dr. Moeller said. “So, if you’re in withdrawal, you have all these symptoms and you wish you were dead. You realize that when you walk out the door of the hospital you can get something that will make you feel better — it’s heroin, or it’s oxycodone, or it’s a pill. Even though you know you just almost died from an overdose, the threat of that happening again is in the future.”

Because of this impulsivity, which is often amplified because of the lifesaving medication, many patients never go to clinics when they’re referred for long-term treatment, opting instead to seek an immediate fix.

What can be changed to better encourage long-term care?

Instead of referring overdose survivors, who are likely experiencing acute withdrawal, to long-term care after they leave the emergency department, Dr. Moeller is testing the effectiveness of initiating long-term treatment before the survivors ever leave the hospital. The goal here is to counteract withdrawal symptoms and reduce impulsivity.

For those who agree to participate, Dr. Moeller’s team, working inside the emergency department, makes contact and provides a medication called buprenorphine that reverses the withdrawal symptoms. Patients are then given a referral within 72 hours to the outpatient clinic, where they continue medication and counseling for addictions.

In addition to administering buprenorphine as early as possible before survivors leave the hospital, the long-term care component of the study is vitally important to the recovery of survivors. In Richmond, referrals to long-term outpatient care guide participants to the VCU Health MOTIVATE Clinic, where social workers, nurses and physicians monitor patients’ progress weekly, provide behavioral counseling sessions in individual and group settings, and administer buprenorphine monthly.

Improving the likelihood that overdose victims reach this long-term component of care is essential, Dr. Moeller said. “Addiction really is a chronic medical disorder. Like diabetes and hypertension, a one-time treatment is not going to solve the problem, so patients need chronic medication and behavioral treatments like group therapy to help them with lifestyle changes.”

Dr. Moeller will serve as principal investigator on the trial and will work with Robert Lipsky, Ph.D., director of translational research in the Department of Neurosciences at Inova Fairfax Hospital, and Warren Bickel, Ph.D., professor of psychiatry and director of the Addiction Recovery Research Center at Virginia Tech Carilion Research Institute. The trial is funded in part by a $500,000 Virginia Catalyst grant from the Virginia Biosciences Health Research Corporation.

If the results show what Dr. Moeller expects, which is a significant drop in repeat overdose and death rates compared to previous data, this trial will establish a new paradigm for treatment of patients after opioid overdose that can be utilized nationally to help survivors get the help they need before it’s too late.

The MCV Foundation encourages and stewards gifts to support research like Dr. Moeller’s that fight all types of diseases. If you’re interested in learning about the tools the Foundation has available to use in making those gifts, visit their giving page.

Inaugural Virginia Clinical Research Conference inspires and strengthens the commonwealth’s clinical research enterprise

T.J. Sharpe addresses the crowd at the Virginia Clinical Research Conference
Metastatic melanoma survivor and clinical research participant T.J. Sharpe talks to Virginia Clinical Research Conference attendees about how clinical trials saved his life. Photo by Kevin Morley, VCU University Relations.

By Anne Dreyfuss
C. Kenneth and Dianne Wright Center for Clinical and Translational Research

The ballroom inside the Hilton Hotel in downtown Richmond was standing room only on Friday morning, when more than 200 clinical research professionals from across the commonwealth gathered for the inaugural Virginia Clinical Research Conference.

“At the end of every clinical trial, there is a family waiting,” keynote speaker T.J. Sharpe said to the crowd of clinical and translational scientists who had assembled for the first conference aimed at strengthening the clinical research enterprise throughout the state. The conference, titled “Engagement: 2019,” was hosted by the Virginia Commonwealth University C. Kenneth and Dianne Wright Center for Clinical and Translational Research with participation from VCU Health and the VCU Office of Research and Innovation.

“We designed the conference as an opportunity to work with academic medical centers across the state,” said Wright Center Director F. Gerard Moeller, M.D. “We wanted to identify ways to become more engaged with one another, as well as the communities we serve, as we work to design, test, and deliver innovative treatment options for patients.” In addition to VCU and VCU Health, attendees hailed from institutions including Eastern Virginia Medical School, the University of Virginia, Virginia Tech Carilion School of Medicine, Inova Health System and Bon Secours Health System.

In his presentation, Sharpe talked about how enrolling in a clinical trial saved his life. In August 2012 — just weeks after the birth of his second child — Sharpe was diagnosed with metastatic melanoma, which is the most dangerous form of skin cancer. His physician gave him less than two years to live. “My purpose wasn’t to be a cancer survivor,” Sharpe said. “It was to be a dad, husband, brother and uncle, but to do that I needed to find a treatment that would give me a chance to fulfill my purpose.”

Knowing the five-year survival rate for metastatic melanoma hovered between 15 and 20 percent, Sharpe enrolled in two clinical trials to try to beat his long odds of survival. Now nearly seven years after the diagnosis and living cancer free, the Fort Lauderdale, Florida-resident has forged a career as a patient advocate and clinical trial experience expert, making it his life’s mission to share the value of clinical research with audiences around the country. “I’m dance dad now on Tuesdays, taking my daughter back-and-forth to dance,” Sharpe said. “These days, my wife and I take the kids on white water rafting trips and go hiking in Maine.”

Sharpe urged the crowd of clinical research professionals to think of him and countless others like him who depend on research they do every day. “My other purpose now is to bring my message to the clinical research world and implore those who have the ability to affect the lives of patients to do so,” he said. “It gave me hope to know there were researchers out there doing incredible work and I wanted to be a part of that. I wanted the opportunity to help other people and make the world a better place through clinical trial participation.”

Wright Center clinical research KL2 scholar Mario Acunzo, Ph.D., speaks with Wright Center director F. Gerard Moeller, M.D., about his research poster. Photo by Kevin Morley, VCU University Relations.

Throughout the daylong conference, attendees discussed how they can work together to help more people like Sharpe. At packed workshops centering on topics including how to engage the community, use big data and work more closely with investigational pharmacists, attendees shared perspectives and collaborated on new opportunities in clinical research.

“Uncovering your unconscious bias makes all the difference in the world as a clinical researcher,” said VCU School of Nursing associate professor Jo Lynne Robins, Ph.D. Robins was a panelist at an interactive workshop on engaging community partners in the practice of clinical research, where researchers and community health providers exchanged experiences and advice for how build better relationships. “The reason we do research is because we want to make a difference in patients’ lives,” Robins said. “We need to find common ground where we’re all committed to the same thing.”

At a breakout session on research ethics, Francis Macrina, Ph.D., posed a hypothesis that it should be possible to tailor a curriculum of responsible research conduct aimed at clinical and translational scientists. “We can and should begin to tailor responsible conduct of research curricula to specific audiences. One size doesn’t fit all anymore,” said the former vice president for research and innovation at VCU.

At the end of the conference, prizes were awarded for poster competition presentations. Thomas Corey Davis, Ph.D., who is an assistant professor and vice chair of clinical affairs in the VCU College of Health Professions Department of Nurse Anesthesia, was awarded the best poster in the category clinical research best practices/quality improvement/process innovations. Elizabeth Krieger, M.D., who is a fellow in the VCU School of Medicine Division of Hematology, Oncology and Palliative Care, was awarded the best poster in the category clinical science research.

“We hope for you to take these discussions beyond this conference,” said Wright Center associate director Antonio Abbate, M.D., Ph.D. At a panel discussion wrapping up the day’s events, Abbate urged conference attendees to apply what they had learned at the conference to their daily research. “There is a person, a face and a smile behind everything that we do,” he said. “Clinical research is an instrument that allows beautiful stories to occur.”

 

Poster competition awardees:

Clinical research

best practices/quality improvement/process innovations:
Title:“Assessing a Novel Method to Reduce Anesthesia Machine Contamination: A Prospective, Observational Trial”

Authors: Thomas Corey Davis, Ph.D., CRNA; Beverly George-Gay, MSN, RN; Praveen Prasanna, M.D.; Emily M. Hill, Ph.D.; Brad Verhulst, Ph.D.; Chuck J. Biddle, Ph.D., CRNA

Clinical science research:
Title: “A Novel KIR-HLA Interaction Scoring System and its Effect on Transplantation Outcomes after HLA Matched Allogeneic Hematopoietic Stem Cell Transplantation”

Authors: Elizabeth Krieger, M.D.; Roy Sabo, Ph.D.; Victoria Okhomina; Catherine Roberts, Ph.D.; Sunauz Moezzi; Caitlin Cain; Marieka Helou, M.D.; John McCarty, M.D., Rizwan Romee M.D.; Rehan Qayyum M.D. MHS; Christina Wiedl, D.O.; Amir Toor, M.D.

Three reasons to attend the inaugural Virginia Clinical Research Conference

On April 12 clinical research professionals from across the state will convene at the Virginia Clinical Research Conference, Virginia’s first statewide conference that is entirely focused on clinical research.

The conference, titled Engagement 2019, is focused on involving stakeholders (patients, families, communities, clinical providers, and research team members) in the planning and conduct of clinical research. Throughout the day, clinical research experts from institutions including Virginia Tech, the University of Virginia and Eastern Virginia Medical School will present on topics ranging from engaging community members in clinical research planning to engaging clinical researchers in research ethics education.

While there are countless reasons for anyone who is interested in clinical research to attend, conference organizers have narrowed it down to three key benefits:

 

  1. Discover opportunities for collaboration

At Engagement 2019, clinical research coordinators, investigators and clinicians will share perspectives, discuss best practices, and collaborate on new opportunities in clinical research. Do you have an idea for a clinical trial, but don’t have access the resources or expertise needed to get it off the ground? The key to turning your idea into action may be at the Virginia Clinical Research Conference.

 

  1. Be inspired

 The conference kicks off with a keynote address by stage 4 melanoma patient T.J. Sharpe, who has undergone six surgeries and four immunotherapy treatments across two clinical trials since being diagnosed in August 2012 with melanoma tumors in multiple organs. The writer, inspirational speaker and consultant to the biopharma and clinical research industries brings a message of hope from the perspective of a patient who is on the road toward overcoming melanoma’s long odds.

 

  1. Advance your career 

More than 200 people from a wide variety of touch-points in the clinical research profession are expected to attend the conference, offering numerous opportunities to network and strengthen the clinical research enterprise throughout the state. In addition to a full day of concurrent presentations, the conference includes networking breaks and research poster viewing opportunities, providing a unique opportunity for clinical research professionals from disparate backgrounds to meet, connect and collaborate on future endeavors.

Wright Center’s Collaborative Advanced Research Imaging facility featured on VCU homepage

The Wright Center’s Collaborative Advanced Research Imaging facility was featured in a Virginia Commonwealth University homepage feature story about technology and innovation at the university. The section on the CARI MRI is below. For the full story, click here.

Cognitive imaging

When Meera Doshi, a psychology major, learned about the principles of magnetic resonance imaging technology in the classroom, she was left with a lot of questions.

However, Doshi honed a deeper understanding of how the technology can be applied as a research tool while working under James Bjork, Ph.D., associate professor of psychiatry in the VCU School of Medicine who oversees the Adolescent Brain Cognitive Development Study. The longitudinal, nationwide study is aimed at increasing the understanding of how environmental, social, genetic and other biological factors affect brain and cognitive development and can disrupt a person’s life trajectory.

Doshi was able to observe a research-dedicated MRI being used to measure adolescent brain development at the VCU Collaborative Advanced Research Imaging Center, part of the university’s C. Kenneth and Dianne Wright Center for Clinical and Translational Research.

“I’ve learned a lot about imaging and when I learn about studies involving imaging in class I have more real-world understanding outside of scientific articles,” Doshi said. “MRI technology wasn’t something I fully understood before. So, actually seeing it in person was extremely helpful to my understanding of the medical technique.”

Currently, students and researchers overseeing studies in the fields of neurology, hepatology, cardiology and substance abuse use the CARI program. In addition to an MRI scanner specifically dedicated to and calibrated for research, the facility offers interview and physical examination rooms, a medication dispensary, staff to operate the MRI scanner and interpret scans, and other resources dedicated to research.

Currently, 47 studies are being conducted at the facility, most of which are focused on substance abuse, said Joel Steinberg, M.D., a research professor in the Wright Center and director of the CARI program.

Steinberg and his team are currently testing the effectiveness of Lorcaserin, a Food and Drug Administration-approved medication for weight loss, in reducing drug cravings in people with cocaine use disorder and opioid use disorder. The CARI MRI scanner would help researchers observe changes in brain physiology that may be related to improvements in patients who are in recovery for substance use disorder.

Steinberg said the CARI MRI scanner is a great tool for understanding how substance abuse disorder is related to abnormal brain physiology.

“No one knows the exact cause of substance use disorder but we’re trying to find that out,” he said. “If we can figure out the mechanisms of how the brain is disordered then perhaps researchers can create treatments targeted to the disordered brain physiology.”

Robert Cadrain, MRI manager of the CARI program, said the students, researchers and medical technologists who use the CARI MRI have a chance to participate in groundbreaking research that affects public health on a large scale. Cadrain operates the CARI MRI scanner to produce images within parameters given by researchers.

“In the clinical setting, someone may come in with an injury and you are helping that one person, but at the CARI facility you are looking at the bigger picture,” Cadrain said. “You are investigating far-reaching problems such as drug addiction and traumatic brain injury and figuring out the mechanisms behind these conditions and how to fix them.”

VCU Wright Center sends six students and faculty members to national translational science conference

This week, more than 1,000 researchers from around the country will descend on the nation’s capital to hear from translational research experts, discuss their research findings, develop their careers, and speak with legislators about the value of scientific research at the Translational Science 2019 conference, held March 5 through 8 in Washington. The Wright Center provided a travel allowance toward attending the conference for six early-career faculty members and students who will be presenting their research posters at the four-day conference. Before they left, we caught up with the researchers to discuss their science, what they were most looking forward to about the conference, and how the Wright Center has supported them with education, training and resources to help improve the translational research process.

 

Hayley Billingsley, graduate student in health and movement sciences, Department of Kinesiology and Health Sciences, VCU College of Humanities and Sciences, and research assistant, Division of Cardiology, Department of Internal Medicine, VCU School of Medicine

“Increased Monounsaturated Fat Consumption is Associated with Improved Body Composition in Subjects with Obesity and Heart Failure with Preserved Ejection Fraction”

Description of research: In a 12-week pilot study aimed at supplementing healthy fats (mono- and polyunsaturated fatty acids) in people who had heart failure with preserved ejection fraction, increasing monounsaturated fatty acids in the diet was associated with a decrease in participants’ percent body fat, which is the amount a person’s weight is composed of fat mass. Monounsaturated fatty acids are found in foods such as extra virgin olive oil, nuts and avocados.

Impact of research: Heart failure patients currently lack evidence-based nutrition therapies. We hope this pilot study will lead to further work exploring the role of mono- and polyunsaturated fatty acids as a potential nutrition therapy for these patients.

Wright Center support: I’m grateful for the Wright Center’s financial support, which has allowed me to attend Translational Science 2019.

Translational Science 2019: I’m looking forward to networking with other research professionals and learning about the NIH grant application process in conference sessions that are aimed at helping young investigators further their research.

 

Justin Canada, Ph.D., assistant professor, Division of Cardiology, Department of Internal Medicine, VCU School of Medicine, and clinical exercise physiologist, VCU Health Pauley Heart Center

“Percent Predicted Peak Exercise Oxygen Pulse is a Marker of Cardiac Reserve Following Thoracic Radiotherapy”

Description of research: Individuals who receive radiation therapy as part of treatment for chest cancers may be at risk of future cardiovascular events due to incidental radiation exposure of the heart. This can lead to symptoms of significant fatigue and shortness of breath before the diagnosis of heart problems. Measuring oxygen consumption changes during exercise may prove to be an early marker of anti-cancer treatment-related toxicity.

Impact of research: In the future, the hope is that this line of research will lead to diagnostic procedures that may help better risk-stratify cancer survivors who may be at risk of cardiotoxicity related to anti-cancer therapies such as radiotherapy and/or chemotherapy.

Wright Center support: This research would not have been possible without the support of the Wright Center, which included providing access to resources at the VCU Medical Center Clinical Research Unit. My research relied on services that were provided at the unit, including phlebotomy and nursing personnel, lab space, and echo and stress testing systems. My mentor, Wright Center associate director Antonio Abbate, M.D., Ph.D., who is also the medical director of the Clinical Research Unit, remains invaluable to my continued learning and growth as a clinical researcher.

Translational Science 2019: The conference hosts a National Institutes of Health Mock Study Section, which provides early-career investigators such as myself with the opportunity to review grant proposals alongside actual NIH study section members. I’m looking forward to hearing the thoughts, questions and concerns that arise as the NIH study section members review my prospective grant applications.

 

Salvatore Carbone, Ph.D., research instructor of medicine, Division of Cardiology, Department of Internal Medicine, VCU School of Medicine, and research nutritionist, VCU Health Pauley Heart Center

“A Dietary Intervention to Increase Unsaturated Fatty Acids in Patients with Obesity and Heart Failure with Preserved Ejection Fraction: An Analysis of the UFA-Preserved Pilot Study

Description of research: We found that a diet aimed at supplementing healthy fats — also called unsaturated fatty acids, — which are found in foods like extra-virgin olive oil, mixed nuts, avocado, canola oil, and fatty fish, —  resembling the Mediterranean dietary pattern, — resulted in positive changes in the levels of fatty acids in the blood, which were in turn associated with improved exercise capacity in patients with obesity and a specific form of heart failure, called heart failure preserved ejection fraction (HFpEF).

Impact of research: About half of patients with heart failure present with HFpEF, and up to 80 percent of those with HFpEF are, in turn, overweight or obese. HFpEF lacks beneficial therapeutic strategies, so we believe the results of our study are important, as they lead to the development of a novel therapeutics in this population. We need to repeat our intervention in a larger population to confirm our findings, but the preliminary data is promising.

Wright Center support: The study was conducted in the VCU Medical Center Clinical Research Unit, which provides state-of-the-art equipment and personnel to perform high-quality research. The study was funded by the Department of Internal Medicine and the VCU Pauley Heart Center, which funds pilot projects to junior faculty like myself who are collaborating with senior faculty members.

Translational Science 2019: Being able to present data is always a great opportunity. I have been working on this project for the past three years, and receiving feedback from investigators from other institution will be very important as I move forward. Additionally, attending the conference allows me to networking with junior faculty like myself and also with senior investigators who have similar research interests, thus facilitating potential future collaboration with researchers from other institutions.

 

Dinesh Kadariya, M.D., assistant professor, Division of Hospital Medicine, Department of Internal Medicine, VCU School of Medicine, and cardiovascular research fellow, VCU Health Pauley Heart Center

“Incidence of Takotsubo Cardiomyopathy in a Large, Urban Hospital in USA”

Description of research: Takotsubo cardiomyopathy, also known as broken heart syndrome, is an acute heart condition in which patients present to a hospital with chest pain. Due to increased awareness, the incidences of this condition being recognized are rising, but the true incidence rate and risk factors are not well known. We evaluated the incidences of takotsubo cardiomyopathy compared to another acute heart condition that can have similar presentation, called non-ST elevated myocardial infarction, in the past eight years at VCU Medical Center.

Impact of research: Although takotsubo cardiomyopathy is typically considered benign, serious complication can happen in some cases. Increased awareness would help clinicians make the diagnosis early. Additionally, having a clearer understanding of risk factors associated with the condition may help to reduce incidences. The study was done for the first time in Richmond, and it will add to the knowledge-base and awareness of the condition among health care providers around the world.

Wright Center support: The Wright Center informatics team provided me with access to the data through TriNetX, which is a system that provides access to patient records in a de-identified, HIPAA-compliant manner. Additionally, Wright Center director F. Gerard Moeller, M.D., and associate director Antonio Abbate, M.D., Ph.D., supervised the design, analysis and presentation of the study.

Translational Science 2019: I’m looking forward to meeting the other conference attendees who are motivated and enthusiastic to discover new things that will advance the medical sciences and help future generations live healthier lives.

 

Amy Northrop, Ph.D. candidate, Department of Human and Molecular Genetics, VCU School of Medicine

“Targeting DDI2 to Potentiate Proteasome Inhibitor-induced Cell Death in Triple-Negative Breast Cancer Cells”

Description of Research: The proteasome is widely regarded as a recycling center in the cell — responsible for degrading proteins that are mutated, misfolded, or not needed by the cell at that time. Cancer cells are highly dependent on the proteasome to degrade the copious amounts of mutant proteins they produce, and allow them to rapidly divide, but proteasome inhibition as a cancer therapy has largely failed to effectively treat most types of cancer. One explanation for this failure is a compensatory cellular mechanism called the NRF1-mediated proteasome bounce-back response, which allows the cell to respond to proteasome inhibition and evade cell death by making more, uninhibited proteasomes to prevent the build-up of proteins that need to be degraded. My research focuses on therapeutically crippling the bounce-back response to allow proteasome inhibitors to more effectively kill many types of cancer cells, thus (hopefully) expanding the repertoire of cancer types for which proteasome inhibition can be used as an effective cancer therapy.

Impact of research: The research is currently focused on triple-negative breast cancer (TNBC), but if we are able potentiate proteasome inhibitor-induced cancer cell killing using TNBC as a model, there may be broader implications for other types of cancer that have also been previously unresponsive to proteasome inhibition as a therapeutic.

Wright Center support: The Wright Center is providing me with a travel allowance to attend the conference. I would neither have submitted an abstract, nor be attending, if it were not for the Wright Center.

Translational Science 2019: I’m most looking forward to participating in the Capitol Hill advocacy visit on Wednesday, where I will join other researchers in meetings with state senators and representatives to talk about the importance of funding clinical and translational science.

 

Cory Trankle, M.D., chief cardiology fellow, Cardiovascular Disease Fellowship, Department of Internal Medicine, VCU School of Medicine

“Interleukin-1 Blockade in Patients with Pulmonary Arterial Hypertension and Right Ventricular Failure” and “Alirocumab in Acute Myocardial Infarction: Results from the Virginia Commonwealth University Alirocumab Response Trial (VCU-AlirocRT)”

Description of research:

“Interleukin-1 Blockade in Patients with Pulmonary Arterial Hypertension and Right Ventricular Failure”: Pulmonary hypertension is a rare, but dangerous disease involving high pressures in the arteries leading to the lungs. Studies involving animal models of pulmonary hypertension suggested that targeted anti-inflammatory therapy could be beneficial in this disease state. We tested, for the first time in this population, an open-label treatment of anakinra in patients with pulmonary arterial hypertension, showing that we could safely reduce the inflammation levels. There were some encouraging additional findings, including that patients felt better overall on the therapy, and the reductions in inflammation were correlated with improvements in their ability to exercise.

“VCU-AlirocRT”: There are two new powerful cholesterol-lowering medications called PCSK9 inhibitors, which are Food and Drug Administration-approved. One of them — alirocumab — has shown that patients with a history of heart attacks (one to 12 months before starting treatment) overall have fewer events (heart attacks, stroke, or death) if they receive this medication. However, there has never been a study evaluating the use of alirocumab at the timeof a heart attack. We tested, for the first time in a randomized, placebo-controlled, double-blind study, the use of alirocumab in patients being admitted to the hospital with a heart attack. We showed that it is safe and effective in lowering the “bad” cholesterol — LDL cholesterol — within 72 hours of a heart attack. Determining if this will result in improved outcomes will require larger studies.

Impact of research: The research could potentially help patients with pulmonary arterial hypertension, which is a rare disease that is in dire need of better treatments, and patients who are coming to the hospital with heart attacks.

Wright Center support: The Wright Center provided the facilities for the pulmonary arterial hypertension study, particularly the VCU Medical Center Clinical Research Unit, which allowed for a one-stop location to provide a wide array of sophisticated testing: cardiopulmonary exercise testing, echocardiography, and phlebotomy with biomarker measurement. The alirocumab study was also supported by the Clinical Research Unit, which allowed for phlebotomy and biomarker measurements and clinical visit coordination.

Translational Science 2019: I’m looking forward to having the opportunity to broadcast our research findings and discuss our research with experts in the field.

VCU researchers participate in a multi-center study to determine the best strategy to improve survival from cardiac arrest

Researchers at Virginia Commonwealth University, along with several other locations throughout the United States, will be performing a research study to determine whiPhoto of a defibrillator on a wallch of two standard strategies of care after a cardiac arrest produces better outcomes.

The study, called the ACCESS Clinical Trial, will include adults who are having a cardiac arrest and have been successfully treated with a defibrillator shock. Cardiac arrest is a medical condition in which the heart stops beating blood to the brain and other organs of the body. It results in death, unless able to be reversed.

Cardiac arrest, commonly known as a heart attack, is often caused by a blockage in one or more of the arteries supplying blood to the heart. Blockages causing heart attacks must be treated urgently with a heart catheterization to prevent significant heart damage. Typically, heart attacks are diagnosed by certain findings on an electrocardiogram, or ECG, performed when the patient arrives in an Emergency Department. After a cardiac arrest, however, heart attacks cannot be reliably identified by the ECG and therefore can go undetected and untreated. Most patients whose heart has been restarted after a cardiac arrest are unconscious and in a coma, so they are unable to provide medical information. Most patients who come out of the coma after several days will then undergo the heart catheterization to look for blockages, but by this time the damage may have already been done to the heart muscle.

The purpose of the ACCESS Clinical Trial is to determine if more of the patients do better if they are taken to receive heart catheterization at the time of admission. Both strategies, early and late heart catheterization, are currently used clinically and both are considered the standard of care, therefore all patients will receive the standard of care treatment.

Since patients are often in a coma after cardiac arrest due to brain injury from when the heart had stopped, they may not be able to give consent. Attempts will be made to contact the patients’ legally authorized representative to obtain consent for the research study. Since the early heart catheterization must be performed within 90 minutes from the time of admission to result in the most benefit, if the legally authorized representative cannot be contacted to provide consent that would allow the procedure to be done within this time frame, the patient will be enrolled into the study under the Department of Health and Human Services regulations allowing an exception to informed consent under emergency research circumstances. 

Interested persons wishing more information, having questions or concerns, or who do not wish to participate in the trial should they experience a cardiac arrest and would like to request an opt-out bracelet, are encouraged to visit https:/z.umn.edu/accesstrial, email access@vcuhealth.org, or call (804) 828 – 6047.

Can liver disease be linked to heart failure? VCU study highlights liver-heart interaction

By Anne Dreyfuss
VCU C. Kenneth and Dianne Wright Center for Clinical and Translational Research

Virginia Commonwealth University researchers have collaborated on a clinical trial that identifies indicators for nonalcoholic fatty liver disease — a typically asymptomatic disease caused by fat buildup in the liver and the leading cause of liver disease in the United States.

Mohammad Siddiqui, M.D., an associate professor in the VCU School of Medicine, and researchers with expertise in cardiology, hepatology, and exercise physiology have been conducting research with a focus on the link between heart and liver damage. Their efforts have resulted in a study in which they draw a connection between patients with aggressive types of fatty liver disease and limitations in exercise capacity.

Read More

A study in the science of play: Does early engagement help premature babies thrive?

The team of researchers was awarded a $2.84 million grant from the National Institutes of Health to facilitate the multi-site clinical trial, “Efficacy of Motor and Cognitive Intervention for Infants Born Preterm (SPEEDI2).”The program is based on two smaller studies using Supporting Play, Exploration and Early Developmental Intervention (SPEEDI) developed through a series of studies at Children’s Hospital of Richmond at VCU. Stacey Dusing, Ph.D., a board-certified pediatric physical therapy specialist and associate professor in the Department of Physical Therapy at VCU and the Department of Pediatrics at CHoR, is the principal investigator for the project and the impetus behind the study concept. Read More

Q&A with Wright Center ClinicalTrials.gov Program Administrator, Alanda Perry Jones

Q&A with ClinicalTrial.gov Program Admininstator, 
Alanda Perry Jones, MA, CCRP
 
During recent workshops, she reviewed a summary of the 2017-2018 changes, delved into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provided resources for researchers to use as they develop their proposals.
What are the takeaways you want from these workshops?
 
The main takeaways are these: NIH has implemented many policy changes over the past year to improve transparency and accountability in human subject research, especially clinical trials. NIH uses a broad interpretation of the definition of a clinical trial. This includes certain mechanistic studies, which are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
What are the major changes?
  1. The funding opportunity announcement (FOAs) will specify whether clinical trials are required, optional, or not allowed.
  2. NIH has revised their proposal form to consolidate and streamline human subjects information. Investigators must use the new Form E.
  3. Multi-site studies must use a single IRB.
What are some of the questions you are getting?
Many investigators are asking whether their particular study qualifies as a clinical trial. Research administrators at VCU can provide guidance on this, but with so many changes occurring at once, the best source of truth is the NIH program officer.
What is your role at the Wright Center for changes like these?
My specific role is ensuring that VCU is compliant with ClinicalTrials.gov regulations, which require outreach and education, as well as input from the research community. The influence of ClinicalTrials.gov over research will likely continue to grow as long as transparency and accountability remain a priority. My goal is to make sure that we’re meeting our important reporting obligations in a way that is as painless as possible.
If you need additional information please visit the National Institute of Health website at:  grants.nih.gov/policy/clinical-trials.htm or contact Alanda Perry Jones at: perryar@vcu.edu