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

Diabetes Mellitus, Type 2 Clinical Trial

— RECORD-AMI  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770687
• Other study ID #: KC19OEDI0591
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2023
• Source: Seoul St. Mary's Hospital
• Contact: Kiyuk Chang, MD, PhD
• Phone: 82-2-2258-1139
• Email: kiyuk[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Infarction
• Myocardial Infarction
• Ventricular Remodeling

Intervention

Drug:
• SGLT2 inhibitor
Patients started on SGLT2 inhibitors after PCI for AMI

Locations

Country	Name	City	State
Korea, Republic of	Seoul St. Mary's Hospital	Seoul

Sponsors (18)

Lead Sponsor

Collaborator

Kiyuk Chang

Andong Hospital, Bucheon St. Mary's Hospital, Chungnam National University Hospital, Daejeon St. Mary's hospital, Incheon St.Mary's Hospital, Inje University, Jeju National University Hospital, Korea University Anam Hospital, Kyungpook National University Hospital, Pusan National University Hospital, Pusan National University Yangsan Hospital, Sejong General Hospital, Seoul St. Mary's Hospital, St Vincent's Hospital, St. Carollo General Hospital, Uijeongbu St. Mary Hospital, Yeouido St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major adverse cardiac and cerebrovascular events	A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization	2 years
Secondary	Cardiac death	Cardiovascular death	2 years
Secondary	Nonfatal myocardial infarction	non-fatal myocardial infarction	2 years
Secondary	Nonfatal stroke	non-fatal stroke	2 years
Secondary	Hospitalization for heart failure	hospitalization for HF	2 years
Secondary	Target lesion revascularization	Revascularization performed for target lesion	2 years
Secondary	Target vessel revascularization	Revascularization performed for target vessel	2 years
Secondary	Non-target vessel revascularization	Revascularization performed for non-target vessel	2 years
Secondary	Definite/Probable stent thrombosis	Definite or probable stent thrombosis	2 years
Secondary	Absolute and percentage change of microalbuminuria	Absolute and percentage change of microalbuminuria	2 years
Secondary	Absolute and percentage change of HbA1c	Absolute and percentage change of HbA1c	2 years
Secondary	Absolute and percentage change of NT-proBNP	Absolute and percentage change of NT-proBNP	2 years
Secondary	Absolute and percentage change of BMI	Absolute and percentage change of BMI	2 years
Secondary	Absolute and percentage change of body weight	Absolute and percentage change of body weight	2 years
Secondary	Changes in echocardiograhic parameters	LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E'	1 year