SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study
- Conditions
- Myocardial InfarctionDiabetes Mellitus, Type 2
- Interventions
- Drug: SGLT2 inhibitor
- Registration Number
- NCT05770687
- Lead Sponsor
- Kiyuk Chang
- Brief Summary
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.
- Detailed Description
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
Bucheon St. Mary's Hospital, Gyeonggi-do, South Korea
Incheon St. Mary's Hospital, Incheon, South Korea
St. Vincent Hospital, Gyeonggi-do, South Korea
Daejeon St. Mary's Hospital, Daejeon, South Korea
After recruitment of all patients, the control group will be selected from a previous prospective cohort (COREA-AMI, NCT02385682) using identical inclusion / exclusion criteria except for use of SGLT2 inhibitors. The control cohort of 3,000 patients will be selected using 1:3 propensity matching.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
- Acute myocardial infarction who were treated with percutaneous coronary intervention
- Type 2 diabetes mellitus
- Started SGLT2 inhibitors <1 month before/after PCI
- Type 1 diabetes mellitus
- Insulin / GLP-1 analogue users
- Previous users of SGLT2 inhibitors
- Pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description SGLT-2 inhibitor SGLT2 inhibitor Patients with naive use of SGLT-2 inhibitors after PCI
- Primary Outcome Measures
Name Time Method Major adverse cardiac and cerebrovascular events 2 years A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization
- Secondary Outcome Measures
Name Time Method Definite/Probable stent thrombosis 2 years Definite or probable stent thrombosis
Absolute and percentage change of BMI 2 years Absolute and percentage change of BMI
Absolute and percentage change of NT-proBNP 2 years Absolute and percentage change of NT-proBNP
Absolute and percentage change of body weight 2 years Absolute and percentage change of body weight
Nonfatal stroke 2 years non-fatal stroke
Cardiac death 2 years Cardiovascular death
Nonfatal myocardial infarction 2 years non-fatal myocardial infarction
Absolute and percentage change of microalbuminuria 2 years Absolute and percentage change of microalbuminuria
Absolute and percentage change of HbA1c 2 years Absolute and percentage change of HbA1c
Changes in echocardiograhic parameters 1 year LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E'
Hospitalization for heart failure 2 years hospitalization for HF
Target lesion revascularization 2 years Revascularization performed for target lesion
Target vessel revascularization 2 years Revascularization performed for target vessel
Non-target vessel revascularization 2 years Revascularization performed for non-target vessel
Trial Locations
- Locations (1)
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of