Background. With approximately 395,000 cases of out-of-hospital cardiac arrests (OHCA) each year in the United States (US) and a national average survival rate of <8%, the public health burden of this disease is enormous. More than 80% of all cardiac arrest survivors with favorable neurological function present with ventricular tachycardia/fibrillation ( VT/VF), making it the presenting cardiac arrest rhythm to be targeted for improvements in treatment and outcome. Seventy percent of patients resuscitated from VT/VF OHCA do not have ST-segment elevation myocardial infarction (no-STEMI) on their 12-lead electrocardiogram. Of these, 45% have acute coronary occlusion or stenosis, a reversible cause amenable to timely percutaneous coronary intervention (PCI). Observational data demonstrates significantly improved functionally favorable survival with early cardiac catheterization laboratory (CCL) activation and treatment in such patients. Despite this, hospital-based delivery of emergent angiography and PCI remains sporadic and inconsistent in the US, caused by the absence of a randomized clinical trial definitively demonstrating improved outcome. Objective/Specific Aim. We propose the first in man, prospective, multicenter, pragmatic, clinical trial determining the survival rate to hospital discharge with favorable function (Modified Rankin Scale Score ? 3) in adults (?18 and ?85 years old) resuscitated from VT/VF OHCA with no-STEMI randomized to receive one of two standard treatments currently provided in the US: 1) early CCL activation and treatment (within 90 minutes of emergency department arrival), versus 2) ICU admission and CCL access only after cardiology consultation and the treating clinician's decision. Methods. A Bayesian adaptive study design and randomization approach will: 1) limit the minimal duration of the study to only three years, and 2) progressively assign more patients to the group with better outcome, potentially providing a clinical advantage to study subjects. The University of Minnesota has been selected as the Data Coordinating Center (DCC), with nationally recognized expertise in Bayesian study design, and successful performance in data management and conduct of multi-center clinical trials. A multiple PD/PI model has been chosen, capitalizing on the complimentary and synergistic specialty expertise of the selected PIs (emergency medicine and interventional cardiology) and their long history of productive and successful collaboration. Participating investigators and study sites have been carefully chosen for internationally recognized expertise in cardiac arrest clinical trials, long-standing collaboration with multi-disciplinary research, and established clinical research infrastructure to efficiently and capably assure successful completion of the proposed investigation. Conclusion. With a realistic estimate of an absolute 15% increase in VT/VF functionally favorable survival rate with early CCL activation and treatment, an additional 6300 to 8200 patients could be saved each year in the US alone.
Two different in-hospital treatments are currently provided in the United States for patients who have return of pulses after out-of-hospital cardiac arrest: 1) emergency coronary angiography (a procedure to look at the arteries of the heart and clear blockages, if they are present), and 2) no emergency coronary angiography (providing this procedure later, if it is indicated). It is unknown which treatment is better. This study will randomize (placing patients into one of these two groups by chance that favors the treatment that, at the current time, is shown to be better) adult patients who have return of pulses after a certain kind of cardiac arrest (called ventricular tachycardia / ventricular fibrillation) to one of these two standard treatments and determine which treatment results in better survival to hospital discharge with good function.
