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）美国（美国）和全国平均生存率<8％，这种疾病的公共卫生烧伤是巨大的。超过80％的心脏骤停生存具有有利的神经功能功能心室心动过速/纤颤（VT/VF），使其成为针对目标的心脏骤停节奏改善治疗和结果。从VT/VF OHCA复苏的患者中有70％DO 在其12铅心电图上没有ST段心电图（NO-STEMI）。的这些，有45％的急性冠状动脉阻塞或狭窄，这是可逆的原因，可及时经皮。冠状动脉干预（PCI）。观察数据证明了功能上有利的显着改善此类患者的早期心脏导管实验室（CCL）激活和治疗的生存。尽管这种基于医院的紧急血管造影和PCI的交付在美国仍然是零星和不一致的，由于缺乏随机临床试验而导致的结果明确证明了预后的改善。客观/特定目标。我们提出了第一个人，前瞻性，多中心，务实，临床试验通过有利的功能确定出院的存活率（修改的Rankin量表得分≤3）在成年人（≥18岁和≤85岁）中，从VT/VF OHCA复活，无肺部随机接收一个美国目前在美国提供的两种标准治疗方法：1）早期CCL激活和治疗（90范围内急诊室到达会议纪要），与2）心脏病学之后的ICU入学和CCL访问咨询和治疗临床决定。方法。贝叶斯自适应研究设计和随机化方法将：1）将研究的最小持续时间限制为仅三年，而2）更多的患者进入该组，以更好的结果，有可能提供临床优势研究主题。明尼苏达大学已被选为数据协调中心（DCC），具有全国认可的贝叶斯研究设计专业知识，并在数据方面取得了成功的表现多中心临床试验的管理和行为。选择了多个PD/PI模型，资本化关于选定PI的免费和协同专业知识（急诊医学和介入心脏病学）及其富有生产力和成功合作的悠久历史。参与研究人员和研究站点已被仔细选择以获得国际认可的心脏专业知识逮捕临床试验，长期与多学科研究合作，并建立了临床研究基础设施有效，有效地确保成功完成拟议的投资。结论。 VT/VF功能良好的存活率的绝对增加15％的现实估计值早期CCL激活和治疗的比率，每年可以将另外6300至8200名患者保存美国一个人。