Effects of Nicorandil on Cardiac Infarct Size in Patients With ST-segment Elevation Acute Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 1
- 主要终点
- Infarct size as measured by cardiac MRI
研究概览
简要总结
We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI
详细描述
The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ST-T elevation MI patients (<12h)
- •undergoing emergency PCI；
- •Subject has read and signed a written, informed consent form.
排除标准
- •SBP<80mmHg；
- •LM stenosis
- •Aortic dissection；
- •AMI (<6 month)
- •PCI 或 CABG (<6 month)
- •Already under the treatment of Nicorandil；
- •Contraindicated or intolerable to Nicorandil
- •severe adverse effects to CMR or MRI；
- •Currently (or within one month) participating in another new drug trial.；
- •Pregnant or lactation period；
- •Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;
研究组 & 干预措施
Treatment arm
Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group);
干预措施: Nicorandil (Drug)
Placebo arm
Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.
干预措施: Placebo (Other)
结局指标
主要结局
Infarct size as measured by cardiac MRI
时间窗: 7 days after primary PCI
The myocardial infarct size was derived by measuring the area of delay-enhanced image-enhanced MRI, which was judged and analyzed by two experienced MRI cardiac diagnosticians.
次要结局
- Corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC)(5 minutes after stent implantation during PCI)
- Incidence of slow flow/no-reflow(5 minutes after stent implantation during PCI)
- CIN(48-72 hours after primary PCI)
- Infarct size as measured by cardiac MRI(6 months after PCI)
- Serum creatinine kinase (CK-MB) level(Baseline, 6, 12, 18, 24 hours after the PCI)
- Microvascular obstructionmeasured by cardiac MRI(7 days after the procedure)
- MACE(up to 12 months)
- ST-segment fall rate of electrocardiogram (ECG)(2 hours after the procedure)
- Edema size (LV area %) measured by cardiac MRI(7 days after the procedure)
- LV Ejection fraction (%) as measured by cardiac MRI(6 months after the procedure)
研究者
Yun Dai Chen
Professor
Chinese PLA General Hospital