The ACCESS Trial - DCC

ACCESS 试验 - DCC

• 批准号: 9352359
• 负责人: John E Connett
• 金额: $ 21.96万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-15 至 2021-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9352359
• 关键词: Accident and Emergency department; Acute; Adherence; Admission activity; Adult; Adverse event; Agreement; Angiography; Bayesian Method; Bayesian Modeling; Biometry; Cardiac; Cardiac Catheterization Procedures; Cardiology; Case Report Form; Certification; Clinical; Clinical Research; Clinical Trials; Clinical Trials Data Monitoring Committees; Collaborations; Consent; Consultations; Coronary Angiography; Coronary Occlusions; Coronary Stenosis; Coronary artery; Data; Data Analyses; Data Coordinating Center; Data Quality; Data Set; Data Storage and Retrieval; Database Management Systems; Databases; Development; Doctor of Philosophy; Documentation; Dropout; Electrocardiogram; Eligibility Determination; Emergency Medicine; Emergency Situation; Evaluation; Event; Head; Heart Arrest; Hospitals; Human Resources; Interdisciplinary Study; International; Intervention; Interview; Investigation; Laboratories; Lead; Masks; Methods; Minnesota; Modeling; Multi-Institutional Clinical Trial; Myocardial Infarction; Nervous System Physiology; Online Systems; Outcome; Patients; Performance; Periodicity; Physiologic pulse; Pragmatic clinical trial; Preparation; Principal Investigator; Procedures; Production; Protocols documentation; Public Health; Public Health Schools; Publications; Randomized; Randomized Clinical Trials; Recommendation; Recording of previous events; Recruitment Activity; Reporting; Research Design; Research Infrastructure; Research Personnel; Resuscitation; Severe Adverse Event; Site; Site Visit; Specific qualifier value; Statistical Data Interpretation; Study Subject; Survival Rate; Survivors; System; Time; Training; Treatment outcome; United States; Universities; Ventricular Fibrillation; Ventricular Tachycardia; Withdrawal; arm; base; burden of illness; clinical research site; cohort; data access; data acquisition; data exchange; data management; design; human very old age (85+); improved; improved outcome; man; medical specialties; mortality; operation; percutaneous coronary intervention; primary outcome; professor; prospective; protocol violation; quality assurance; screening; secondary outcome; standard care; treatment group

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.

背景。美国每年约有39.5万例院外心脏骤停（OHCA）