A Randomised Trial Evaluating the Safety and Efficacy of a Single Low Dose of Intracoronary Insulin-like Growth Factor-1 Following Percutaneous Coronary Intervention for ST-Elevation Acute Myocardial Infarction (RESUS-AMI)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Serum glucose measurement
研究概览
简要总结
When a patient has a heart attack, a blockage occurs in a coronary artery that delivers oxygen to the heart muscle. The heart muscle may weaken, causing heart failure. The body naturally makes a protein called insulin-like growth factor-1 (IGF-1) that may protect the heart muscle cells from dying and may prevent heart failure or lessen the damage that occurs. IGF-1 is also available as a drug called mecasermin. In this study, heart attack patients will be given either a dose of mecasermin or a placebo (inactive treatment) after their coronary artery has been opened by a stent. The purpose of the study will be to evaluate the safety of the therapy and to test if the therapy will prevent or lessen heart failure by evaluating a cardiac magnetic resonance imaging (MRI) taken one day and eight weeks after the heart attack.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75
- •Presents within 2-12 hours of at least 30 minutes of myocardial ischemic pain
- •ECG evidence of myocardial infarction
- •Undergoing percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction
- •Left ventricular ejection fraction during PCI of 40% or less
- •TIMI flow grade 3 in the infarct-related artery following reperfusion and stenting
排除标准
- •History of prior myocardial infarction
- •Prior history of heart failure, left ventricular dysfunction or cardiomyopathy
- •Active or suspected neoplasia
- •Known impaired liver function
- •Cardiogenic shock
- •Estimated glomerular filtration rate < 45 ml/min/1.73m2
- •History of hypoglycaemia requiring hospitalisation
- •History of primary insulin-like growth factor-1 deficiency or growth hormone disorders
- •Contraindication to cardiac magnetic resonance imaging
- •Pregnancy or nursing mothers
- •Known allergy to study drug or any of its inactive ingredients
- •Treatment with another investigational agent within 30 days of enrolment
- •Subjects unable or unwilling to comply with follow-up requirements of study
- •Subjects unable to provide written informed consent
研究组 & 干预措施
mecasermin low dose
干预措施: mecasermin (Drug)
mecasermin high dose
干预措施: mecasermin (Drug)
saline placebo
干预措施: 0.9% sodium chloride injection (Drug)
结局指标
主要结局
Serum glucose measurement
时间窗: 30 minutes after study drug administration
Safety outcome measure
Percent change in global left ventricular ejection fraction (LVEF) measured by quantitative cardiac magnetic resonance imaging (MRI)
时间窗: Baseline and 8 weeks
Efficacy outcome measure
次要结局
未报告次要终点
研究者
Professor Noel Caplice
Professor of Cardiovascular Sciences
University College Cork