Advanced REperfusion STrategies- The ARREST Trial

先进的再灌注策略 - ARREST 试验

• 批准号: 10022312
• 负责人: TOM Paul AUFDERHEIDE
• 金额: $ 55.4万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-21 至 2021-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022312
• 关键词: Accident and Emergency department; Achievement; Acute; Admission activity; Adult; Adverse event; Amiodarone; Blinded; Blood Circulation; Cardiac Catheterization Procedures; Cardiopulmonary Bypass; Caring; Categories; Cerebrum; Cessation of life; Chronic; Clinical; Clinical Trials; Coin; Collaborations; Communities; Coronary; Coronary Arteriosclerosis; Coronary Occlusions; Coronary Stenosis; Cost Analysis; Data; Death Rate; Determination of Death; Devices; Extracorporeal Membrane Oxygenation; Future; Heart Arrest; Hospitals; Incidence; Infrastructure; Institutes; Intention; Investments; Laboratories; Life; Measures; Mechanics; Minnesota; Multi-Institutional Clinical Trial; Nervous System Physiology; Patients; Performance; Perfusion; Phase; Physiologic pulse; Population; Protocols documentation; Public Health; Randomized; Refractory; Reperfusion Therapy; Research; Research Personnel; Resuscitation; Role; Safety; Shock; Subgroup; Survival Rate; Survivors; System; Time; United States; Universities; Ventricular Fibrillation; Ventricular Tachycardia; aged; base; clinically significant; cost; efficacy clinical trial; experience; functional status; hemodynamics; improved; individual patient; mortality; out-of-hospital cardiac arrest; outcome forecast; patient population; percutaneous coronary intervention; prospective; randomized trial; relative cost; secondary endpoint; standard of care; syntax; treatment strategy

Project Summary/Abstract Background: Approximately 395,000 people suffer out-of-hospital cardiac arrest (OHCA) each year in the US. The survival rate is <6%. Although ventricular tachycardia/fibrillation (VT/VF) constitutes only 30-35% of all cardiac arrests, more than 80% of survivors present with VT/VF. These patients are also likely to have an underlying reversible cause. Patients with refractory VT/VF, who have been emergently transported to the cardiac catheterization laboratory (CCL) with CPR in progress, have been shown to have a >80% incidence of clinically significant coronary stenosis. Thus, VT/VF is a strong predictor of acute coronary occlusion or stenosis, potentially amenable to timely percutaneous coronary intervention (PCI). The refractory VT/VF population with the worst prognosis (15% death rate) has the highest incidence of a treatable underlying cause. This subgroup offers the greatest opportunity to impact OHCA survival and public health. Advanced perfusion/reperfusion strategies now make it feasible to potentially reverse the underlying cause, including mechanical CPR, and extracorporeal membrane oxygenation (ECMO) before and/or after PCI. Thus, investigators submitting this application implemented a Refractory VT/VF Protocol as a standard of care in Minneapolis/St. Paul through the comprehensively integrated, and collaborative Minnesota Resuscitation Consortium (MRC). During the first 12 months of protocol implementation, 62 sequential patients entered the CCL with CPR in progress. Overall, survival to hospital discharge occurred in 28(45%) and functionally favorable survival (Cerebral Performance Category 1 or 2) occurred in 26 (42%). Of the survivors, 26/28 (90%) had CPC 1 at one month. Historical and concurrent data for the same population receiving standard resuscitation practice in MSP show survival of 15% with CPC 1 OR 2. Proposed Clinical Trial We propose a single center, prospective feasibility/efficacy clinical trial, to assess the role of early ECMO-facilitated CCL access compared to ED based resuscitation when ROSC is required for CCL access. Both strategies represent current standards of care in our community. Two EMS systems transport patients to the ED where resuscitation is continued until ROSC, followed by CCL access, or death is declared. Three EMS systems transport patients to the University of MN for the ECMO-based early CCL access protocol. Our 18-month preliminary experience shows that ECMO-based early CCL patients have higher functionally favorable survival rates than conventional resuscitation practice. Specific Aim. Compare the rates of survival to hospital discharge with Modified Rankin Scale Score (mRS) ≤3 in adult patients (18-75 years old) with refractory VT/VF OHCA that are mobilized early to the U of MN and randomized to receive either: 1) continued ED based resuscitation until achievement of ROSC followed by CCL access and PCI or determination of death, or 2) early CCL access for ECMO support and PCI when needed. Assess the cost associated with such a strategy. Significance. If our study results indicate potential efficacy, it will provide the basis for a future multicenter clinical trial to assess definitive survival benefit and generalizability of this approach.

项目概要/摘要 背景：美国每年约有 395,000 人发生院外心脏骤停 (OHCA)。 存活率<6%。尽管室性心动过速/颤动 (VT/VF) 仅占所有心动过速/颤动 (VT/VF) 的 30-35% 心脏骤停后，超过 80% 的幸存者出现 VT/VF。这些患者也可能患有 潜在的可逆原因。被紧急转运至救治中心的难治性 VT/VF 患者 心导管实验室 (CCL) 进行心肺复苏，已显示出 >80% 的发生率 有临床意义的冠状动脉狭窄。因此，VT/VF 是急性冠状动脉闭塞或狭窄的有力预测因子， 可能适合及时经皮冠状动脉介入治疗（PCI）。难治性 VT/VF 人群 最差的预后（15% 死亡率）具有最高的可治疗根本原因的发生率。这个小组 提供了影响 OHCA 生存和公共健康的最佳机会。高级灌注/再灌注 现在的策略使得扭转根本原因成为可能，包括机械心肺复苏，以及 PCI 之前和/或之后进行体外膜肺氧合 (ECMO)。因此，调查人员提交此 应用程序在明尼阿波利斯/圣路易斯实施了难治性 VT/VF 协议作为护理标准。保罗通过 全面整合、协作的明尼苏达复苏联盟 (MRC)。前12年期间 在方案实施的几个月内，62 名连续患者进入 CCL 并进行心肺复苏。全面的， 28 人（45%）存活至出院，并且功能良好的存活（脑功能 类别 1 或 2) 发生在 26 例 (42%) 中。在幸存者中，26/28 (90%) 在一个月时患有 CPC 1。历史和 在 MSP 中接受标准复苏实践的同一人群的并发数据显示存活率为 15% 与 CPC 1 或 2。 拟议的临床试验 我们提出单中心、前瞻性可行性/有效性临床试验 试验，旨在评估 ROSC 时早期 ECMO 辅助的 CCL 通路与基于 ED 的复苏的作用 CCL 访问需要。这两种策略都代表了我们社区当前的护理标准。两个特快专递 系统将患者运送到急诊室，在那里继续进行复苏直至 ROSC，然后进行 CCL 访问，或 死亡被宣告。三个 EMS 系统将患者运送到明尼苏达大学进行基于 ECMO 的早期 CCL 访问协议。我们18个月的初步经验表明，基于ECMO的早期CCL患者有更高的 与传统的复苏实践相比，功能上的存活率更高。具体目标。比较费率 成年患者（18-75 岁）改良 Rankin 量表评分 (mRS) ≤ 3 的出院生存率 患有难治性 VT/VF OHCA 且早期被动员到明尼苏达大学并随机接受以下任一治疗：1) 继续基于 ED 的复苏，直至实现 ROSC，然后进行 CCL 访问和 PCI 或确定 死亡，或 2) 在需要时早期获得 ECMO 支持和 PCI 的 CCL。评估与此类相关的成本 一个策略。意义。如果我们的研究结果表明潜在的功效，它将为未来提供基础 多中心临床试验评估该方法的明确生存获益和普遍性。