Effects of Erythropoietin on Infarct Size and Left Ventricular Remodeling in Survivors of Large Myocardial Infarctions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 223
- 试验地点
- 16
- 主要终点
- Infarct Size in the Territory of the Infarct Related Artery
研究概览
简要总结
The purpose of this study is to evaluate whether erythropoietin can help limit the damage to the heart in patients with acute heart attacks.
详细描述
REVEAL is a randomized, double-blinded, placebo-controlled, parallel phase II clinical study that will evaluate the effects of erythropoietin administration on infarct size, left ventricular remodeling and circulating endothelial progenitor cells in patients with large myocardial infarctions (MI). The study will be conducted in two phases: a dose-escalation safety phase and a single dose efficacy phase. Eligible patients who present to the hospital with an acute ST-elevation MI and who agree to participate in this study will be randomly assigned to receive a single infusion of study medication consisting either of erythropoietin or placebo. The size of the infarction and the dimensions of the heart will be assessed by cardiac magnetic resonance imaging (MRI) within 2-6 days of the infusion of the study medication, and again approximately 3 months later.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Escalation Safety
The objective of the first phase is to evaluate the safety of escalating doses of Epoetin alfa in patients with STEMIs.
干预措施: Epoetin alfa (Drug)
Single Dose Efficacy
Single parenteral administration of 60000 U of epoetin alfa. The objectives of the second phase are to investigate the effects of the highest safe dose on infarct size, left ventricular remodeling and endothelial progenitor cells.
干预措施: Epoetin alfa (Drug)
结局指标
主要结局
Infarct Size in the Territory of the Infarct Related Artery
时间窗: performed 2 to 6 days after study medication administration (first CMR)
Infarct size, expressed as percentage of LV mass, assessed by cardiac magnetic resonance (CMR) imaging.
次要结局
- Infarct Size in the Territory of the Infarct Related Artery(12 ± 2 weeks after study medication)
- LV Ejection Fraction(2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR))
- LV Volume Indexed to BSA(2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR))
- LV Mass Indexed to BSA(2 to 6 days after study medication administration (first CMR) and 12 ± 2 weeks later (second CMR))
- Vital Signs(baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days)
- Hemoglobin Levels(baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days)
- Reticulocyte Counts(baseline, 24 hours, 48 hours, 14 (+/- 5) days, and 30 (+/- 5) days)
- Number of Participants With Clinical Events(from randomization to second CMR)