Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 911
- 试验地点
- 13
- 主要终点
- Progression of Acute Coronary Syndrome to Myocardial Infarction
研究概览
简要总结
The purpose of this study is to test the impact of pharmacological myocardial metabolic support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the treatment of patients with threatened or established acute myocardial infarction (AMI).
详细描述
BACKGROUND:
Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), myocardial infarction (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 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.
DESIGN NARRATIVE:
This is a randomized, placebo-controlled, double-blinded, multicenter clinical trial of IMMEDIATE GIK as early as possible in ACS in the prehospital emergency medical service (EMS) setting. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI or STEMI in prehospital EMS. The primary hypothesis is that early GIK will prevent or reduce the size of acute myocardial infarction. Major secondary hypotheses posit GIK will reduce mortality (30 days and 1 year), reduce pre- or in-hospital cardiac arrest and the propensity for heart failure. Other hypotheses address mechanisms of these effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms of threatened or established AMI including but not limited to:
- •Chest pain, discomfort, or tightness
- •Arm or shoulder pain
- •Epigastric discomfort
- •Shortness of breath
- •12-lead electrocardiogram (ECG) with two or more contiguous leads with ST elevation greater than 1 mm, ST depression greater than 0.5 mm, T wave inversion or other T wave abnormalities (hyperacute T waves), or left bundle branch block (not known to be old). Identification aided by the acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI)and thrombolytic predictive instrument (TPI) decision support software (ACI-TIPI >= 75% and TPI detection of suspected STEMI).
排除标准
- •End-stage kidney failure requiring dialysis
- •Rales present more than halfway up the back
- •Unable to comply with the requirements of the study
- •Incarcerated
- •Known to be pregnant
研究组 & 干预措施
1 -- GIK
GIK = glucose-insulin-potassium; In one-liter: Dextrose 30% + 80 mEq Potassium Chloride + 50 units Regular Insulin; infused at 1.5 ml/kg/hour for a total of 12 hours.
干预措施: GIK (Drug)
2 -- Placebo
Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
干预措施: Placebo (Drug)
结局指标
主要结局
Progression of Acute Coronary Syndrome to Myocardial Infarction
时间窗: 24 hours
Outcome for all participants during the first 24 hours of hospitalization; evidence of myocardial infarction is determined by ECG and biomarker results.
次要结局
- Cardiac Arrest(1 to 18 hours (From prehospital setting through hospitalization.))
- Heart Failure or Death(30 days)
- Mortality(30 days)
- Cardiac Arrest or Acute Mortality(Prehospital setting through hospitalization)