A cardiac arrest research study will be performed in Cincinnati and several other locations in the United States under the Department of Health and Human Services regulations for exception from informed consent in emergency circumstances. The study will include adult victims of out-of-hospital cardiac arrest who are transported to University of Cincinnati Medical Center (UCMC). The study will start in August 2018 and enroll patients for five years.
Cardiac arrest is the sudden loss of normal heart and lung function. A clot in the heart arteries, also called a "heart attack,” is one cause of cardiac arrest. Patients are known to have a clot if there are certain signs on their electrocardiogram, also called an ECG. These patients are taken to the cardiac catheterization lab to have an invasive procedure to remove the clot and restore blood flow to their heart. However, previous research has shown that patients who have an out-of-hospital cardiac arrest due to certain irregular heart rhythms may have a clot but not show signs on their ECG. The purpose of this research study is to determine if these patients do better if initially transported to the cardiac catheterization lab or initially transported to the intensive care unit for stabilization. All patients will receive standard medical care and will be randomized to one of these two options, similar to flipping a coin.
This study meets federal regulations for exception from informed consent in emergency circumstances because informed consent cannot be obtained from a victim of out-of-hospital cardiac arrest, and there is reasonable scientific evidence to suggest a possible benefit from these interventions. For details on the risks and benefits, exception from informed consent, opt-out bracelets, and other aspects of the study, please call 513-584-0477, email firstname.lastname@example.org, or visit the website at z.umn.edu/accesstrial.