NCT01875484已完成不适用
Impact of Circulating miR-126 on Left Ventricular Remodeling and Clinical Outcomes in Patients Undergoing Primary Percutaneous Coronary Intervention. The PMIR-miR-126 Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,200
- 试验地点
- 17
- 主要终点
- Change in LVEDV from baseline by 3D-echocardiogram
研究概览
简要总结
Purpose: The purpose of this study is to evaluate the impact of circulating miR-126 on left ventricular remodeling and clinical outcomes in patients undergoing primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes;
- •Age ≥18 years;
- •Informed consent from patient or next of kin.
排除标准
- •Nonischaemic Cardiomyopathy;
- •Cardiac surgery planed in the 6 months;
- •Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation);
- •Renal or hepatic failure;
- •Malignancy, HIV, or central nervous system disorder;
- •Cardiopulmonary resuscitation >15 min and compromised level of consciousness;
- •Cardiogenic shock;
- •Current participation in any research study involving investigational drugs or devices;
- •No written consensus;
- •Previous myocardial infarction.
结局指标
主要结局
Change in LVEDV from baseline by 3D-echocardiogram
时间窗: 6 months
The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) at 6 months post-PCI by 3D-echocardiogram.
次要结局
- Stent thrombosis(6 months)
- Peak troponin T level(24 hours after PCI)
- Major adverse cardiovascular events (MACE)(6 months)
- All cause mortality(6 months)
- Change in LVESV from baseline(6 months)
- NT-proBNP levels(at 1 and 180 days post-PCI)
- Incidence of complete ST-segment resolution(3 hours after PCI)
研究者
Pan-Pan Hao
MD, PhD
Qilu Hospital of Shandong University
研究点 (17)
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