Intracoronary Nitroprusside for the Prevention of the No-Reflow Phenomenon Following Primary Percutaneous Coronary Intervention in Acute Myocardial Infarction. A Randomized, Double Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
研究概览
简要总结
In patients admitted with acute myocardial infarction, there is a total occlusion of a coronary artery. Even after emergency catheterization and angioplasty, in some patients, the resumed blood flow is suboptimal and impacts on heart function. The study is aimed at examining whether nitroprusside, an anti-hypertension medication, given directly into the coronary artery, can improve the blood flow after the removal of the obstruction that caused the infarction.
详细描述
Inadequate myocardial tissue perfusion despite successful relief of the culprit occlusion and restoration of epicardial coronary flow for ST-segment elevation acute myocardial infarction (STEMI) results in poor outcome. The investigators hypothesized that nitroprusside (NTP) injected intracoronary immediately before angioplasty might prevent no-reflow and improve vessel flow and myocardial perfusion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ST elevation myocardial infarction (MI) patients planned for primary PCI
- •Diagnostic angiography demonstrating a TIMI flow grade <3 in the coronary artery before the PCI
排除标准
- •An admission electrocardiogram (ECG) showing complete left bundle branch block or a paced rhythm
- •Systolic blood pressure < 90 mmHg
- •A history of coronary bypass operation
- •A known allergic reaction to nitroprusside
- •Chronic hemodialysis
- •Intravenous drug abuse
- •Pregnancy
- •Rescue intervention after failed thrombolysis
- •Contraindications to aspirin or clopidogrel
- •Need for emergent coronary artery bypass surgery
- •Inability to provide informed consent
结局指标
主要结局
The coronary blood flow in the artery undergoing intervention following angioplasty as determined by the corrected Thrombolysis in Myocardial Infarction (TIMI) frame count (CTFC)
Proportion of patients with complete ST-segment resolution immediately after percutaneous coronary intervention (PCI)
次要结局
- The proportion of patients with TIMI grade 3 flow after the procedure
- The proportion of patients with myocardial grade 3 blush after the procedure
- The proportion of patients with complete ST-segment resolution at 24 hours post intervention
- The proportion of patients requiring intra-aortic balloon counter-pulsation and its duration of use
- Length of hospital stay
- The combined rate of target vessel revascularization, myocardial infarction or death at 180 days