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 whi
ch 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.
Study update 8/19/20:
This study was performed at 26 research sites throughout the United States and Canada. Richmond was to be was one of the sites that performed this research but the study was ended before any subjects in Richmond could be entered. Patients were included in the study following informed consent with the patient, their next-of-kin, or using exception from informed consent under emergency circumstances if the patient was unable to speak and next-of-kin could not be found. A total of 65 patients were entered into the ACCESS trial between January, 2018 and July, 2019; 68% were male with an average age of 64 years. Of the 65 patients, 75% were Caucasian, 15% were African-American, 8% were of unknown race, 1.6% were Native American, 1.6% were Asian, 3% of patients were Hispanic, and 23% were of unknown ethnicity.
Study Results:
The ACCESS trial was stopped early, in July, 2019, because the rate of subject enrollment was too low. The study results showed no difference in patient outcomes between treatment with initial admission to the cardiac catheterization laboratory compared to initial ICU admission, including survival and functionally favorable survival at hospital discharge and 3 months following hospital discharge.
For additional information, please contact Joseph Ornato at (804) 828-5250 or via email at joseph.ornato@vcuhealth.org.
Categories Clinical Research, Clinical Trials, Collaboration, Research