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

Kiyuk Chang

Status: Enrolling

Conditions: Myocardial Infarction; Diabetes Mellitus, Type 2

Treatments: Drug: SGLT2 inhibitor

Study type: Observational

Funder types: Other

Identifiers

NCT05770687

KC19OEDI0591

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

SGLT-2 inhibitor

Description:

Patients with naive use of SGLT-2 inhibitors after PCI

Treatment:

Drug: SGLT2 inhibitor