The ACCESS Trial - DCC

ACCESS 试验 - DCC

基本信息

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
项目类别：
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

项目摘要

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) 病例。美国（US）全国平均生存率<8%，这种疾病的公共卫生负担是超过 80% 的心脏骤停幸存者具有良好的神经功能室性心动过速/颤动 (VT/VF)，使其成为针对的心脏骤停心律 70% 的 VT/VF OHCA 复苏患者的治疗和结果有所改善。 12 导联心电图上没有 ST 段抬高型心肌梗死 (no-STEMI)。其中 45% 患有急性冠状动脉闭塞或狭窄，这是一种可逆的原因，需要及时经皮介入治疗冠状动脉介入治疗（PCI）的观察数据表明功能显着改善。此类患者通过早期心导管实验室（CCL）激活和治疗来生存。在美国，以医院为基础的紧急血管造影和 PCI 的实施仍然是零星且不一致的，由于缺乏明确证明结果改善的随机临床试验而造成。目的/具体目标我们提出了第一个人体、前瞻性、多中心、务实的临床试验。确定功能良好的出院存活率（改良Rankin量表评分≤3）从 VT/VF OHCA 复苏且无 STEMI 的成人（≥18 岁且≤85 岁）随机接受一项美国目前提供的两种标准治疗方法： 1) 早期 CCL 激活和治疗（90 年内到达急诊室的分钟数），对比 2）仅在心脏病学后进入 ICU 并进入 CCL 咨询和治疗临床医生的决定。贝叶斯适应性研究方法。随机化方法将：1）将研究的最短持续时间限制为三年，以及 2）逐步将更多患者分配到具有更好结果的组，可能提供临床优势明尼苏达大学被选为数据协调中心（DCC），拥有全国公认的贝叶斯研究设计专业知识以及数据方面的成功表现选择了多中心临床试验的管理和实施。所选 PI（急诊医学和介入心脏病学）以及他们富有成效和成功合作的悠久历史。研究人员和研究地点均经过精心挑选，拥有国际公认的心脏病专业知识逮捕临床试验，与多学科研究长期合作，建立临床试验研究基础设施，以高效、有力地确保成功完成拟议的调查。结论：根据实际估计，VT/VF 绝对增加 15%，有利于功能性生存。通过早期 CCL 激活和治疗，每年可挽救 6300 至 8200 名患者的生命仅美国。