Metabolic Modulation With Metformin to Reduce Heart Failure After Acute Myocardial Infarction: Glycometabolic Intervention as Adjunct to Primary Coronary Intervention in ST Elevation Myocardial Infarction (GIPS-III): a Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 380
- 试验地点
- 1
- 主要终点
- Improvement in Left Ventricular Ejection Fraction
研究概览
简要总结
The investigators will evaluate the effect of metformin therapy during 4 months in non-diabetic patients following ST-elevation myocardial infarction on left ventricular ejection fraction as measured with cardiac magnetic resonance imaging, compared to placebo.
详细描述
In this trial, the investigators will evaluate the effect of metformin therapy following ST-elevation myocardial infarction (STEMI) in a total of 380 non-diabetic patients. This trial is a randomized, double blind, controlled trial. The intervention, which consist of metformin 500mg twice daily or placebo twice daily, will commence within three hours after the percutaneous coronary intervention, and will be continued for 4 months. The primary endpoint is the difference between the two intervention groups (metformin vs placebo) in left ventricular ejection fraction, as measured with magnetic resonance imaging after 4 months. The investigators hypothesize that metformin therapy results in a significantly higher ejection fraction in this population.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The diagnosis acute MI defined by chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 12 hours before hospital admission, and an ECG recording with ST- segment elevation of more than 0.1 mV in 2 or more leads.
- •Successful primary PCI (post-procedural TIMI 2/3);
- •At least one stent sized ≥ 3.0 mm;
- •Eligible for 3T CMR imaging;
- •Verbal followed by written informed consent.
排除标准
- •rescue PCI after thrombolytic therapy;
- •need for emergency coronary artery bypass grafting;
- •creatinin >177 μmol/L measured pre-PCI;
- •Younger than 18 years;
- •Mechanical ventilation;
- •Diabetes;
- •Prior myocardial infarction;
- •Contra-indication to metformin (see safety);
- •The existence of a life-threatening disease with a life-expectancy of less than 6 months.
研究组 & 干预措施
Metformin
metformin 500mg twice daily during 4 months
干预措施: Metformin (Drug)
Placebo
Placebo twice daily during 4 months
干预措施: Placebo (Drug)
结局指标
主要结局
Improvement in Left Ventricular Ejection Fraction
时间窗: 4 months
The primary efficacy parameter of the GIPS-III trial is LVEF measured by cardiac MRI 4 months after randomization, based on an intention-to-treat analysis. It is hypothesized that metformin therapy will result in a higher ejection fraction after 4 months.
次要结局
- Glycometabolic State(4 months and long-term follow-up)
- Diastolic Function(4 months)
- Myocardial Infarct Size and Transmural Extent of Infarction as Measured With Cardiac Magnetic Resonance Imaging(4 months after hospitalization)
- Cardiac MRI After 4 Months, Per Protocol Analysis(4 months)
- the Incidence of a Cardiovascular Event(4 months and longterm follow-up)
- Markers of Heart Failure and Glycometabolic State(4 months and longterm follow-up)
研究者
Chris Lexis
Drs.
University Medical Center Groningen