SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients With Acute Myocardial Infarction, a Prospective, Multi-center Registry Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Myocardial Infarction, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: SGLT2 inhibitor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SGLT-2 inhibitor<br>Patients with naive use of SGLT-2 inhibitors after PCI | Drug: SGLT2 inhibitor<br>* Patients started on SGLT2 inhibitors after PCI for AMI<br>* Other names: dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac and cerebrovascular events | A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac death | Cardiovascular death | 2 years | 
| Nonfatal myocardial infarction | non-fatal myocardial infarction | 2 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous Coronary Intervention, SGLT-2 inhibitor