Reversal of No-reflow/Slow-flow During Percutaneous Coronary Intervention in Patients With Acute Myocardial Infarction--a Prospective Randomized Study Comparing Intracoronary Infusion of Diltiazem, Verapamil and Nitroglycerin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Vessel flow using TIMI flow grade and TIMI frame count
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of three different vasodilators including diltiazem, verapamil and nitroglycerin for reversal of no-reflow/slow-flow during direct percutaneous coronary intervention for acute myocardial infarction.
详细描述
No-reflow/slow-flow is a frequent observation during direct PCI for AMI and associated with a poor clinical outcome. The present pharmacological management involves the use of different vasodilators including nitrates, verapamil, adenosine and nicorandil. But no randomized trial has been conducted to assess any of these agents, or to determine the appropriate dosage. This prospective randomized study aimed to confirm favorable effects of diltiazem on no-reflow/slow-flow during direct PCI for AMI compared with verapamil and nitroglycerin.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute myocardial infarction
- •Vessel TIMI flow < grade Ⅲ post-PCI
排除标准
- •Heart failure of New York Heart Association (NYHA) class Ⅲ to class Ⅳ
- •Sick sinus syndrome
- •Atrioventricular block (grade Ⅱ and above)
- •SBP ≤ 90mmHg or cardiogenic shock
- •Heart Rate ≤60 bpm
- •Pregnancy
- •Renal or hepatic failure
研究组 & 干预措施
D
If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of diltiazem via an infusion microcatheter distal to the angioplasty site was performed.
干预措施: Diltiazem (Drug)
V
If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of verapamil via an infusion microcatheter distal to the angioplasty site was performed.
干预措施: Verapamil (Drug)
N
If no-reflow/slow-flow phenomenon was observed post-PCI, intracoronary infusion of nitroglycerin via an infusion microcatheter distal to the angioplasty site was performed.
干预措施: Nitroglycerin (Drug)
结局指标
主要结局
Vessel flow using TIMI flow grade and TIMI frame count
时间窗: post-PCI
次要结局
- major adverse cardiovascular events (MACE)(within the first 30 days after PCI)
- Left ventricular ejection fraction (LVEF) through echocardiography(at 1 and 30 days post-PCI)
- NT-proBNP levels(at 1 and 30 days post-PCI)
- incidence of complete ST-segment resolution(3 hours after PCI)
- peak troponin T level(24 hours after PCI)
研究者
Ge Junbo
Director of Cardiology Department
Fudan University