Clinical trial NCT05770687: SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocardial Infarction
Diabetes Mellitus, Type 2
Keywords: Percutaneous Coronary Intervention
SGLT-2 inhibitor
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Seoul St. Mary's Hospital
name: Uijeongbu St. Mary Hospital
name: Incheon St.Mary's Hospital
name: Daejeon St. Mary's hospital
name: Bucheon St. Mary's Hospital
name: St Vincent's Hospital
name: Yeouido St. Mary's Hospital
name: Sejong General Hospital
name: Pusan National University Hospital
name: Andong Hospital
name: Chungnam National University Hospital
name: St. Carollo General Hospital
name: Pusan National University Yangsan Hospital
name: Kyungpook National University Hospital
name: Jeju National University Hospital
name: Korea University Anam Hospital
name: Inje University
First posted: 2023-03-15
Enrollment: 1000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction

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.

Eligibility criteria: 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

Primary outcomes:
measure: Major adverse cardiac and cerebrovascular events
timeFrame: 2 years
Secondary outcomes:
measure: Cardiac death
timeFrame: 2 years
measure: Nonfatal myocardial infarction
timeFrame: 2 years
measure: Nonfatal stroke
timeFrame: 2 years
measure: Hospitalization for heart failure
timeFrame: 2 years
measure: Target lesion revascularization
timeFrame: 2 years
measure: Target vessel revascularization
timeFrame: 2 years
measure: Non-target vessel revascularization
timeFrame: 2 years
measure: Definite/Probable stent thrombosis
timeFrame: 2 years
measure: Absolute and percentage change of microalbuminuria
timeFrame: 2 years
measure: Absolute and percentage change of HbA1c
timeFrame: 2 years
measure: Absolute and percentage change of NT-proBNP
timeFrame: 2 years
measure: Absolute and percentage change of BMI
timeFrame: 2 years
measure: Absolute and percentage change of body weight
timeFrame: 2 years
measure: Changes in echocardiograhic parameters
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kiyuk Chang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: