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.

背景资料。在美国，每年约有395,000例院外心脏骤停 美国(US)和全国平均存活率为&lt；8%，这种疾病造成的公共卫生负担是 巨大的。在所有神经功能良好的心脏骤停幸存者中，超过80%的人患有 室性心动过速/室颤(VT/VF)，使其成为目前的心脏骤停节律的靶点 在治疗和结果方面的改进。70%的VT/VF uchA患者复苏后 12导联无ST段抬高心肌梗死(NO-STEMI)。的 这些患者中有45%患有急性冠状动脉闭塞或狭窄，这是一种可逆的原因，可以及时经皮穿刺术 冠状动脉介入治疗(PCI)。观测数据显示，功能显著改善，有利 早期心导管实验室(CCL)激活和治疗对此类患者的存活率。尽管 这种以医院为基础的急诊血管造影术和介入治疗在美国仍然是零星的和不一致的， 这是由于没有一项随机临床试验明确证明结果有所改善所致。 目标/特定目标。我们提出了首个人、前瞻性、多中心、实用的临床试验。 判定功能良好的出院存活率(改良朗肯评分≤3) 成人(≥18岁和≤85岁)从室性心动过速/室颤中复苏，无ST段抬高心肌梗死，随机接受一次 美国目前提供的两种标准治疗方法：1)早期CCL激活和治疗(在90内 急诊室到达的分钟数)，而2)只有在心脏病后才能进入ICU和CCL 会诊和治疗由临床医生决定。方法：研究方法。贝叶斯自适应研究的设计与实现 随机化方法将：1)将研究的最短持续时间限制在只有三年，以及2) 逐步将更多的患者分配到结果更好的组，潜在地提供临床优势 来研究科目。明尼苏达大学被选为数据协调中心(DCC)， 具有国家认可的贝叶斯研究设计专业知识，并在数据方面取得成功 管理和实施多中心临床试验。选择了多重PD/PI模型，大写 关于选定的私人投资机构的免费和协同专业知识(紧急医学和 介入心脏病学)以及他们卓有成效和成功合作的悠久历史。参与 研究人员和研究地点经过精心挑选，以获得国际公认的心脏病专业知识 停止临床试验，与多学科研究长期合作，并建立临床 研究基础设施，以高效和有能力地确保成功完成拟议的调查。 结论。VT/VF功能良好存活率绝对增加15%的现实估计 早期激活和治疗CCL，每年可额外节省6300至8200名患者 仅美国一国。