Clinical Study on Reducing Myocardial Infarction Siez After Primary PCI in Patients With ST Segment Elevation Myocardial Infarction by Using Henagliflozin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Area under the curve of myocardial enzymes (CK-MB)
研究概览
简要总结
This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI). A total of 240 patients were enrolled in either Henagliflozin group or control group. Patients in Henggliflozin group will be given by oral administration of Henggliflozin for 6 months post acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes were monitored. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure. This study aims to assess the impact of Henggelizin intervention on the reduction of myocardial infarction size (evaluated by cardiac enzyme) and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction.
详细描述
This Randomized controlled intervention study recruited patients diagnosed with ST-segment elevation myocardial infarction (STEMI) who were scheduled to undergo emergency percutaneous coronary intervention (PCI) . A total of 240 patients were selected for both the Henagliflozin group and control group. In the emergency room, clinical data would be collected, along with peripheral venous blood samples for laboratory examination. This examination should include blood routine analysis, myocardial enzyme, blood glucose levels, liver and kidney function, and brain natriuretic peptide precursor (NT proBNP) measurement. After primary PCI, Henggliflozin was administered, followed by daily oral administration of one tablet until 6 months post-acute myocardial infarction. Prior to procedure, dynamic changes in myocardial enzymes and electrocardiogram were monitored, with subsequent monitoring at 6 hours, 24 hours, and 48 hours after myocardial infarction. Perioperative complications were documented, followed by cardiac ultrasound assessments of myocardial wall motion and cardiac structure at seven days post primary PCI and six months post procedure. Major cardiovascular events, including non-fatal myocardial infarction, all-cause death, revascularization due to angina, and hospitalization for acute heart failure, were observed through follow-up at 1 month, 2 months, 3 months, and 6 months after PCI. This study aims to assess the impact of postoperative Henggelizin intervention on the reduction of myocardial infarction size and improvement of left ventricular remodeling in patients with ST-segment elevation myocardial infarction (STEMI).
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 (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 with clear diagnosis: ischemic chest pain lasting for more than 30 minutes and adjacent to two or more leads of ST Segment elevation (limb lead ≥ 0.1mV, chest lead ≥ 0.2mV) with or without elevated myocardial enzyme levels;
- •Chest pain lasting less than 12 hours;
- •Age range from 18 to 80 years old;
- •Plans to undergo primary PCI ;
- •Informed consent form
排除标准
- •Mechanical complications;
- •Cardiogenic shock;
- •Experienced myocardial infarction within 6 months;
- •Aortic dissection;
- •Suffering from malignant tumors, severe liver and kidney failure, respiratory failure, or other short-term progressive diseases that researchers believe cannot be included
- •Urinary system infection
研究组 & 干预措施
henagliflozein group
Patients in henagliflozein group was given henagliflozein once a day for 6 months after myocardial infarction.
干预措施: Henagliflozin (Drug)
结局指标
主要结局
Area under the curve of myocardial enzymes (CK-MB)
时间窗: 3 days after the primary PCI
Postoperative dynamic monitoring of myocardial enzyme （CK-MB）changes post infarction
次要结局
- Infarct size(7 days after the primary PCI)
- Cardiovascular adverse events(12 months after primary PCI)
- contrast induced by nephropathy(5 days after the primary PCI)
- Left ventricular remodeling(6 months after primary PCI)
- renal function renal function Renal function(6 months after primary PCI)
研究者
Qian geng
MD
Chinese PLA General Hospital