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.

项目总结/摘要 背景：美国每年约有395，000人在院外心脏骤停（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/颤动的30-35%， 心脏骤停时，超过80%的幸存者出现VT/VF。这些患者也可能有 潜在的可逆原因。患有难治性VT/VF的患者，已被紧急转运至 心导管实验室（CCL）与CPR进行中，已被证明有>80%的发病率， 临床显著冠状动脉狭窄。因此，VT/VF是急性冠状动脉闭塞或狭窄的强预测因子， 可能适合于及时的经皮冠状动脉介入治疗（PCI）。难治性VT/VF人群 最差的预后（15%的死亡率）具有可治疗的潜在原因的最高发生率。该亚组 为影响OHCA的生存和公共卫生提供了最大的机会。晚期灌注/再灌注 现在的策略使潜在的逆转根本原因变得可行，包括机械心肺复苏术， 体外膜肺氧合（ECMO）在PCI之前和/或之后。因此，研究人员提交了这份 应用程序实施了一项难治性室性心动过速/室颤方案，作为明尼阿波利斯/圣保罗通过 明尼苏达复苏联盟（Minnesota Resuscitation Consortium，MRC）前12 在方案实施的几个月内，62名连续患者进入CCL，进行CPR。总的来说， 28例患者（45%）存活至出院，功能良好的存活率（脑功能 1类或2类）发生在26例（42%）。在存活者中，26/28（90%）在1个月时有CPC 1。历史和 在MSP中接受标准复苏实践的同一人群的同期数据显示， CPC 1或2。建议的临床试验我们建议进行一项单中心、前瞻性可行性/有效性临床试验， 试验，评估ROSC时早期ECMO促进的CCL进入与基于艾德的复苏相比的作用 是CCL访问所必需的。这两种策略都代表了我们社区目前的护理标准。两个EMS 系统将患者运送到艾德，在那里继续复苏，直到ROSC，然后进入CCL，或 死亡被宣布。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患者具有更高的 比传统的复苏实践更有利的生存率。具体目标。比较价格 成人患者（18-75岁）中改良兰金量表评分（mRS）≤3的生存至出院的百分比 患有难治性VT/VF OHCA的患者，早期动员到MN的U，并随机接受：1） 持续基于艾德的复苏，直至达到ROSC，随后进行CCL入路和PCI或确定 或2）早期CCL通路，以便在需要时进行ECMO支持和PCI。评估与此相关的成本 一个策略意义如果我们的研究结果显示出潜在的疗效，它将为未来的研究提供基础。 多中心临床试验，以评估明确的生存获益和这种方法的普遍性。