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)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Myocardial Infarction; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: SGLT2 inhibitor

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Kiyuk Chang, MD, PhD; Phone Number: 82-2-2258-1139; Email: [email protected]

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul St. Mary's Hospital
    • Contact: Kiyuk Chang; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SGLT-2 inhibitor; Patients with naive use of SGLT-2 inhibitors after PCI	Drug: SGLT2 inhibitor; Patients started on SGLT2 inhibitors after PCI for AMI; Other Names: dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kiyuk Chang
• Collaborators: Seoul St. Mary's Hospital; Pusan National University Hospital; Korea University Anam Hospital; Kyungpook National University Hospital; Inje University; St Vincent's Hospital; Jeju National University Hospital; Pusan National University Yangsan Hospital; Sejong General Hospital; Chungnam National University Hospital; Bucheon St. Mary's Hospital; Incheon St.Mary's Hospital; Uijeongbu St. Mary Hospital; Daejeon St. Mary's hospital; Yeouido St. Mary's Hospital; Andong Hospital; St. Carollo General Hospital
• Investigators: Principal Investigator: Kiyuk Chang, MD, PhD, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: March 5, 2023
• First Submitted That Met QC Criteria: March 5, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; SGLT-2 inhibitor
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pathological Conditions, Anatomical; Myocardial Infarction; Infarction; Diabetes Mellitus, Type 2; Ventricular Remodeling; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Dapagliflozin; Empagliflozin; Ertugliflozin; Sodium-Glucose Transporter 2 Inhibitors; Ipragliflozin
• Other Study ID Numbers: KC19OEDI0591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No