Arrhythmia Assessment Core Lab for IMMEDIATE Trial

心律失常评估核心实验室立即进行试验

• 批准号: 7122513
• 负责人: ERIC J RASHBA
• 金额: $ 13.54万
• 依托单位: STATE UNIVERSITY NEW YORK STONY BROOK
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-15 至 2010-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7122513
• 关键词: acute disease /disorder; angina pectoris; antiarrhythmic agent; arrhythmia; blood chemistry; cardiovascular disorder chemotherapy; cardiovascular disorder prevention; cardiovascular disorder risk; chemoprevention; clinical research; clinical trials; coronary disorder; fatty acid metabolism; fatty acid transport; free fatty acids; glucose; heart arrest; human subject; human therapy evaluation; insulin; intravenous administration; myocardial infarction; patient oriented research; pharmacokinetics; potassium; sudden cardiac death

DESCRIPTION (provided by applicant): Basic and clinical research by our team and others suggests intravenous glucose, insulin, and potassium (GIK)I metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris I (UAP) to acute myocardial infarction (AMI), MI size, and mortality. Also, for ST elevation MI (STEMI), GIK may prolong time of benefit of coronary reperfusion. These effects should reduce short- and long-term mortality from acute coronary syndromes (ACS: including AMI and UAP) and the propensity for heart failure (HF). These benefits are related to the earliness of ACS, when both risk and opportunity to save lives are highest. Thus, we propose the IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized placebo-controlled clinical trial of immediate GIK as early as possible in ACS: in the prehospital emergency medical service (EMS) setting, or, for those presenting to emergency departments (EDs), immediately upon ED arrival. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI (or STEMI), and its use in prehospital EMS and ED settings. Our primary hypothesis is that early GIK will reduce 30-day and 1-year mortality. Major secondary hypotheses posit GIK will reduce pre/in-hospital cardiac arrest, progression of UAP to AMI, and by this and limiting MI size, will reduce the propensity for HF. Other hypotheses address mechanisms of these effects. The project will take 5 years: a year preparing and testing operations, 28 months enrolling patients, and then completion of data collection, analysis, and reporting. Clinical sites will be in Massachusetts, Texas, and Wisconsin; this application is for trial coordination at Tufts-New England Medical Center (accompanying are 3: for Data Coordinating Center and 2 Core Laboratories). Inclusion of 15,450 patients (excluding AMI Killip class >2) should provide >80% statistical power to detect 25% reductions in primary endpoints (30-day and 1-year mortality) and major secondary endpoints (cardiac arrest or mortality, and HF hospitalization or mortality, and progression of UAP to AMI). A 400-subject cohort assessed for LV function, ventricular arrhythmia markers, and biochemical tests, will provide >80% power for clinically relevant differences between GIK and placebo. If the 30-50% reduction in acute mortality rates in prior GIK trials and reductions in HF are confirmed, this inexpensive treatment could substantially reduce the most common causes of death and hospitalization in the US. (End of abstract.)

描述（由申请人提供）： 我们的团队和其他人的基础和临床研究表明，静脉葡萄糖，胰岛素和钾（GIK）I代谢心肌支持减少缺血引起的心律失常，从不稳定的心绞痛I（UAP）到急性心肌梗死（AMI），MI大小，MI大小，MI肌肉I（UAP）的发展和死亡率。同样，对于ST升高MI（STEMI），GIK可能会延长冠状动脉再灌注的益处。这些影响应降低急性冠状动脉综合征（ACS：包括AMI和UAP）的短期和长期死亡率以及心力衰竭倾向（HF）。 这些好处与ACS的早期性有关，何时挽救生命的风险和机会最高。因此，我们提出了立即（在急诊评估和治疗期间立即进行心肌代谢增强）试验，这是一项随机的安慰剂对照对照ACS的立即GIK的临床试验：在院前紧急医疗服务（EMS）设置，或者，对于急诊部门（ED）的人，ED到达后立即。与先前和正在进行的GIK试验不同，这将测试GIK的所有AC，而不是仅针对AMI（或STEMI），及其在院前EMS和ED设置中的使用。 我们的主要假设是，GIK早期将降低30天和1年的死亡率。主要的次要假设GIK将减少前/医院心脏骤停，UAP向AMI的发展，并且通过这种限制MI大小，将减少HF的倾向。其他假设解决了这些影响的机制。该项目将花费5年：一年准备和测试操作，28个月招募患者，然后完成数据收集，分析和报告。临床场所将在马萨诸塞州，德克萨斯州和威斯康星州。该申请是在塔夫茨新英格兰医学中心进行试用协调（随附3：用于数据协调中心和2个核心实验室）。包括15,450名患者（不包括AMI Killip类> 2）应提供> 80％的统计功率，以检测主要终点（30天和1年死亡率）和主要的次要终点（心脏骤停或死亡率以及HF住院）的25％降低。或死亡率，以及UAP向AMI的发展。评估LV功能，心室心律失常标记和生化测试的400个受试者队列将为GIK和安慰剂之间的临床相关差异提供> 80％的功率。如果在先前的GIK试验中降低了30-50％的急性死亡率和HF的降低，则这种廉价的治疗可以大大减少美国最常见的死亡和住院原因。 （摘要结束。）