Advanced REperfusion STrategies- The ARREST Trial

先进的再灌注策略 - ARREST 试验

• 批准号: 9791473
• 负责人: TOM Paul AUFDERHEIDE
• 金额: $ 73.62万
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9791473
• 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; clinical efficacy; clinically significant; cost; 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.

项目摘要/摘要 背景：在美国，每年约有395,000人发生院外心脏骤停。 存活率为6%。尽管室性心动过速/室颤(VT/VF)只占所有室性心动过速/纤颤的30-35% 心脏骤停，超过80%的幸存者出现室速/室颤。这些患者还可能有一种 潜在的可逆原因。难治性室速/室颤患者，已被紧急转移到 心导管实验室(CCL)正在进行心肺复苏，已被证明有80%的发病率 临床上有明显的冠状动脉狭窄。因此，VT/VF是急性冠状动脉闭塞或狭窄的有力预测指标， 有可能接受及时的经皮冠状动脉介入治疗(PCI)。难治性室速/室颤患者 最差的预后(15%的死亡率)具有最高的可治疗潜在原因发生率。这个子组 提供了最大的机会来影响HCA的生存和公共健康。晚期灌流/再灌注 现在，战略使潜在地扭转根本原因成为可能，包括机械心肺复苏术，以及 术前和(或)术后行体外膜氧合(ECMO)。因此，提交这份报告的调查人员 应用程序通过以下方式在明尼阿波利斯/圣保罗实施了难治性VT/VF协议作为护理标准 全面整合和协作的明尼苏达州复苏联盟(MRC)。在前12个月 经过几个月的方案实施，62名序贯患者进入CCL，并进行CPR。总的来说， 存活到出院的有28例(45%)，功能良好的存活(脑功能表现 第1类或第2类)26例(42%)。存活者中，26/28(90%)在1个月时发生了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% 建议的临床试验我们提出了一个单一中心、预期的可行性/有效性的临床试验 试验，以评估早期ECMO促进的CCL接入与基于ED的复苏在ROSC时的作用 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 系统将患者送到急诊室，在那里继续复苏，直到ROSC，然后进入CCL，或者 宣布死亡。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 功能上的存活率比传统的复苏方法更好。明确目标。比较一下价格 成人患者(18-75岁)应用改良兰金量表评分(MRS)≤3对出院后生存率的影响 难治性VT/VF uchA早期被动员到MN的U，并随机接受以下任一项：1) 继续基于ED的复苏，直到达到ROSC，然后进行CCL接入和经皮冠状动脉介入治疗或确定 死亡，或2)早期CCL访问以获得ECMO支持和需要时的PCI。评估与此相关的成本 一种策略。意义重大。如果我们的研究结果表明了潜在的疗效，它将为未来的 多中心临床试验，以评估该方法的最终生存益处和推广能力。