Real World Observation of SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiac and cerebrovascular events
研究概览
简要总结
Prospective trials performed on type 2 diabetes patients without established cardiovascular disease has shown that SGLT2 inhibitors reduce cardiovascular risk. No studies have yet examined the occurrence of cardiovascular disease in patients with acute myocardial infarction.
The investigators designed the current study to evaluate the most ideal oral hypoglycemic agent in type 2 diabetes patients undergoing percutaneous coronary intervention for acute myocardial infarction. The investigators hypothesize that the use of SGLT-2 inhibitors will reduce cardiovascular events and modify left ventricular remodeling after myocardial infarctions.
详细描述
8 hospitals of the Catholic University of Korea with high-volume percutaneous coronary intervention of following hospitals are participating in the current study.
Seoul St. Mary's Hospital, Seoul, South Korea
Yeoido St. Mary's Hospital, Seoul, South Korea
Uijongbu St. Mary's Hospital, Gyeonggi-do, South Korea
Eunpyeong St. Mary's Hospital, Seoul, South Korea
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute myocardial infarction who were treated with percutaneous coronary intervention
- •Type 2 diabetes mellitus
- •Started SGLT2 inhibitors <1 month before/after PCI
排除标准
- •Type 1 diabetes mellitus
- •Insulin / GLP-1 analogue users
- •Previous users of SGLT2 inhibitors
- •Pregnancy
研究组 & 干预措施
SGLT-2 inhibitor
Patients with naive use of SGLT-2 inhibitors after PCI
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events
时间窗: 2 years
A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization
次要结局
- Cardiac death(2 years)
- Nonfatal stroke(2 years)
- Nonfatal myocardial infarction(2 years)
- Absolute and percentage change of microalbuminuria(2 years)
- Absolute and percentage change of HbA1c(2 years)
- Changes in echocardiograhic parameters(1 year)
- Hospitalization for heart failure(2 years)
- Target lesion revascularization(2 years)
- Target vessel revascularization(2 years)
- Non-target vessel revascularization(2 years)
- Definite/Probable stent thrombosis(2 years)
- Absolute and percentage change of BMI(2 years)
- Absolute and percentage change of NT-proBNP(2 years)
- Absolute and percentage change of body weight(2 years)
研究者
Kiyuk Chang
MD, PhD
Seoul St. Mary's Hospital