Diabetes Mellitus, Type 2, Myocardial Infarction
Conditions
Keywords
Percutaneous Coronary Intervention, SGLT-2 inhibitor
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.
Interventions
DRUGSGLT2 inhibitor
Patients started on SGLT2 inhibitors after PCI for AMI
Sponsors
Seoul St. Mary's Hospital
Uijeongbu St. Mary Hospital
Incheon St.Mary's Hospital
Daejeon St. Mary's hospital
Bucheon St. Mary's Hospital
St Vincent's Hospital
Yeouido St. Mary's Hospital
Sejong General Hospital
Pusan National University Hospital
Andong Hospital
Chungnam National University Hospital
St. Carollo General Hospital
Pusan National University Yangsan Hospital
Kyungpook National University Hospital
Jeju National University Hospital
Korea University Anam Hospital
Inje University
Kiyuk Chang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute myocardial infarction who were treated with percutaneous coronary intervention * Type 2 diabetes mellitus * Started SGLT2 inhibitors \<1 month before/after PCI
Exclusion criteria
* Type 1 diabetes mellitus * Insulin / GLP-1 analogue users * Previous users of SGLT2 inhibitors * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | 2 years | A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nonfatal stroke | 2 years | non-fatal stroke |
| 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 |
| Cardiac death | 2 years | Cardiovascular death |
| Non-target vessel revascularization | 2 years | Revascularization performed for non-target vessel |
| 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 |
| Absolute and percentage change of NT-proBNP | 2 years | Absolute and percentage change of NT-proBNP |
| Absolute and percentage change of BMI | 2 years | Absolute and percentage change of BMI |
| Absolute and percentage change of body weight | 2 years | Absolute and percentage change of body weight |
| Changes in echocardiograhic parameters | 1 year | LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E' |
| Definite/Probable stent thrombosis | 2 years | Definite or probable stent thrombosis |
Countries
South Korea
Contacts
Primary ContactKiyuk Chang, MD, PhD
Outcome results
None listed