The ACCESS Trial - DCC

ACCESS 试验 - DCC

• 批准号: 9154793
• 负责人: John E Connett
• 金额: $ 25.29万
• 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/9154793
• 关键词: Accident and Emergency department; Accounting; 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; Interview; Investigation; Laboratories; Lead; Masks; Methods; Minnesota; Modeling; Multi-Institutional Clinical Trial; Myocardial Infarction; Nervous System Physiology; Online Systems; Outcome; Patients; Performance; 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; Reporting; Research; Research Design; Research Infrastructure; Research Personnel; 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 acquisition; data exchange; data management; 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.

背景每年约有395，000例院外心脏骤停（OHCA）， 美国（US）和全国平均生存率<8%，这种疾病的公共卫生负担是 巨大的。在所有具有良好神经功能的心脏骤停幸存者中，超过80%存在以下症状： 室性心动过速/室颤（VT/VF），使其成为靶向治疗的当前心脏骤停节律 改善治疗和结果。70%的VT/VF OHCA复苏患者 在12导联心电图上没有ST段抬高型心肌梗死（非STEMI）。的 这些患者中，45%患有急性冠状动脉闭塞或狭窄，这是一种可逆的原因，可以及时经皮 冠状动脉介入治疗（PCI）。观察数据表明，功能上的显著改善有利于 早期心导管实验室（CCL）激活和治疗这些患者的生存率。尽管 在美国，基于医院的紧急血管造影术和PCI的实施仍然是零星的和不一致的， 这是由于缺乏明确证明结果改善的随机临床试验。 目的/具体目标。我们提出了第一个在人，前瞻性，多中心，务实，临床试验 确定功能良好的出院生存率（改良兰金量表评分≤ 3分） 在VT/VF OHCA复苏的成人（≥18岁且≤85岁）中，无STEMI，随机接受一种治疗 美国目前提供的两种标准治疗：1）早期CCL激活和治疗（90 到达急诊科的时间（分钟），对比2）仅在心脏科检查后进入ICU和CCL 咨询和治疗临床医生的决定。方法.贝叶斯适应性研究设计和 随机化方法将：1）将研究的最短持续时间限制为仅3年，以及2） 逐渐将更多患者分配到结局更好的组，可能提供临床优势 来研究课题明尼苏达大学被选为数据协调中心（DCC）， 在贝叶斯研究设计方面具有全国公认的专业知识， 管理和开展多中心临床试验。选择了多个PD/PI模型， 就选定的私家医生（急症医学及 介入心脏病学）和他们富有成效和成功合作的悠久历史。参与 研究者和研究地点经过精心挑选，具有国际公认的心脏病学专业知识， 逮捕临床试验，与多学科研究的长期合作，并建立了临床 研究基础设施，以有效和有能力地确保成功完成拟议的调查。 结论VT/VF功能有利生存率绝对增加15%的现实估计 早期CCL激活和治疗，每年可额外挽救6300至8200名患者， 美国独自。