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| Name | Class |
|---|---|
| Seoul St. Mary's Hospital | OTHER |
| Uijeongbu St. Mary Hospital | OTHER |
| Incheon St.Mary's Hospital | OTHER |
| Daejeon St. Mary's hospital |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SGLT-2 inhibitor | Patients with naive use of SGLT-2 inhibitors after PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SGLT2 inhibitor | Drug | Patients started on SGLT2 inhibitors after PCI for AMI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiac and cerebrovascular events | A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiac death | Cardiovascular death | 2 years |
| Nonfatal myocardial infarction | non-fatal myocardial infarction | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kiyuk Chang, MD, PhD | Contact | 82-2-2258-1139 | kiyuk@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Kiyuk Chang, MD, PhD | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital | Recruiting | Seoul | South Korea |
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| OTHER |
| Bucheon St. Mary's Hospital | OTHER |
| St Vincent's Hospital | OTHER |
| Yeouido St. Mary's Hospital | OTHER |
| Sejong General Hospital | OTHER |
| Pusan National University Hospital | OTHER |
| Andong Hospital | UNKNOWN |
| Chungnam National University Hospital | OTHER |
| St. Carollo General Hospital | UNKNOWN |
| Pusan National University Yangsan Hospital | OTHER |
| Kyungpook National University Hospital | OTHER |
| Jeju National University Hospital | OTHER |
| Korea University Anam Hospital | OTHER |
| Inje University | OTHER |
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| Nonfatal stroke | non-fatal stroke | 2 years |
| Hospitalization for heart failure | hospitalization for HF | 2 years |
| Target lesion revascularization | Revascularization performed for target lesion | 2 years |
| Target vessel revascularization | Revascularization performed for target vessel | 2 years |
| Non-target vessel revascularization | Revascularization performed for non-target vessel | 2 years |
| Definite/Probable stent thrombosis | Definite or probable stent thrombosis | 2 years |
| Absolute and percentage change of microalbuminuria | Absolute and percentage change of microalbuminuria | 2 years |
| Absolute and percentage change of HbA1c | Absolute and percentage change of HbA1c | 2 years |
| Absolute and percentage change of NT-proBNP | Absolute and percentage change of NT-proBNP | 2 years |
| Absolute and percentage change of BMI | Absolute and percentage change of BMI | 2 years |
| Absolute and percentage change of body weight | Absolute and percentage change of body weight | 2 years |
| Changes in echocardiograhic parameters | LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E' | 1 year |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077203 | Sodium-Glucose Transporter 2 Inhibitors |
| C529054 | dapagliflozin |
| C570240 | empagliflozin |
| C570288 | ertugliflozin |
| C572941 | ipragliflozin |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D007004 | Hypoglycemic Agents |
| D045505 | Physiological Effects of Drugs |
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