Researchers at Virginia Commonwealth University, along with several other locations throughout the United States, will be performing a research study to determine which 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 email@example.com, or call (804) 828 – 6047.