Chinese People's Liberation Army General Hospital
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Myocardial infarct size according to MR delayed enhancement scan
研究概览
简要总结
This study aim to investigate the myocardium protection effect of cardiomyopeptidin in patients undergoing primary PCI for ST-elevation myocardial infarction through myocardial enhanced MRI.
详细描述
Investigators will enroll 160 patients with STEMI who were admitted to the Chinese PLA General Hospital between March 2022 and Marchr 2024，the investigators randomly assign eligible patients in a 1:1 ratio to either cardiomyopeptidin intervention group or control group befor primary PCI. The cardiomyopeptidin intervention group patients received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation. Primary end point of the study was the area of infarct size measured by cardiac magnetic resonance (CMR). and secondary endpoints include slow flow/no-reflow incidence, corrected TIMI frame count (cTFC), ST-segment fall rate of ECG, cardiac enzymes and troponin, area of myocardial edema, microvascular obstruction, left ventricular ejection fraction, and composite cardiovascular events during the study period: all-cause death, cardiovascular death, unplanned hospitalization for heart failure, and revascularization. All adverse clinical events as well as study end points were monitored and adjudicated by the independent event committee.
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
- •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
- •had once treated by ivabradine
- •history of myocardial infarction
- •mechanical complications
- •Unable to perform myocardial MRI
- •liver and kidney failure
- •malignant tumor
- •unconscious
- •Patients with other significant abnormal signs, laboratory tests and clinical disease are unsuitable for participation in the study accessed by clinicians.
研究组 & 干预措施
Cardiomyopeptidin group
The Cardiomyopeptidin group received intravenous infusion 3 mg/(kg·d) of cardiomyopeptidin during the PCI until 3 days after operation
干预措施: cardiomyopeptidin (Drug)
结局指标
主要结局
Myocardial infarct size according to MR delayed enhancement scan
时间窗: 7 days after PCI
Two experienced MRI cardiologists analyzed the delayed enhancement image
次要结局
- myocardial edema area(7 days after PCI)
- MACEs(follow up in six months)
- microvascular obstruction and left ventricular ejection fraction(7 days after PCI)
- incidence of slow flow/no-reflow(Immediately after PCI)
- corrected thrombolysis in myocardial infarction (TIMI) frame count (cTFC);(Immediately after PCI)
- ST-segment fall rate of electrocardiogram (ECG)(6 hours, 12 hours, 24 hours after myocardial infarction)
研究者
Qian geng
Clinical Professor
Chinese PLA General Hospital