Chinese People's Liberation Army General Hospital
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- TIMI flow grade
研究概览
简要总结
Giving preoperative loading dose of 60mg of trimetazidine can safely and effectively reduce the PCI-related myocardial damage for the patients undergoing selective PCI. but the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction is not sure. this study aim to study the effect of Trimetazidine during the primary PCI on cardiac function in patients with ST-elevation myocardial infarction.
详细描述
Investigators will enroll 240 patients with STEMI who were admitted to the Chinese PLA General Hospital between Januay 2017 and August 2017. STEMI was defined as typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T. We randomly assign eligible patients in a 1:1 ratio to either 60mg of trimetazidine or oral placebo befor PCI. Trimetazidine group will accept 20mg of trimetazidine for 12 months after PCI and active Comparator will be given placebo for 12 months after PCI.
Primary end point of the study was the area of viable myocardium coming from MR delayed enhancement scan and main cardiovascular events concluding recurrent myocardial infarction, cardiac death, recurrent angina, acute heart failure. Secondary end point of the study was the change of LVEF. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee. Each patient was contacted in every week after administration of the contrast, investigated main cardiovascular events (myocardial infarction,acute heart failure and death), and record any adverse events.
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
- •STEMI patients: typical chest pain lasting 30 min within the previous 12 h, a clear ST-segment elevation of N0.1 mV in ≥2 contiguous electrocardiographic leads, and elevated blood levels of troponin T
- •patients were scheduled to undergo diagnostic cardiac angiography or percutaneous coronary interventions
排除标准
- •The combined use of trimetazidine contraindications;
- •had cardiogenic shock,
- •had a history of myocardial infarction, stent thrombosis, or renal insufficiency;
- •had previously undergone coronary artery bypass surgery.
研究组 & 干预措施
Trimetazidine group
Trimetazidine 60 mg 30 min before PCI and 20 mg for 12 months after surgery
干预措施: Trimetazidine (Drug)
结局指标
主要结局
TIMI flow grade
时间窗: immediately post procedure
main cardiovascular events
时间窗: follow up in one year
Myocardial infarct size according to MR delayed enhancement scan
时间窗: 3 to 5 days after PCI
次要结局
- change of the LVEF(follow up in one year)
研究者
Qian geng
Chinese People's Liberation Army General Hospital
Chinese PLA General Hospital
