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)

March 5, 2023 updated by: Kiyuk Chang

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SGLT-2 inhibitor
Patients with naive use of SGLT-2 inhibitors after PCI
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
Time Frame: 2 years
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
Time Frame: 2 years
Cardiovascular death
2 years
Nonfatal myocardial infarction
Time Frame: 2 years
non-fatal myocardial infarction
2 years
Nonfatal stroke
Time Frame: 2 years
non-fatal stroke
2 years
Hospitalization for heart failure
Time Frame: 2 years
hospitalization for HF
2 years
Target lesion revascularization
Time Frame: 2 years
Revascularization performed for target lesion
2 years
Target vessel revascularization
Time Frame: 2 years
Revascularization performed for target vessel
2 years
Non-target vessel revascularization
Time Frame: 2 years
Revascularization performed for non-target vessel
2 years
Definite/Probable stent thrombosis
Time Frame: 2 years
Definite or probable stent thrombosis
2 years
Absolute and percentage change of microalbuminuria
Time Frame: 2 years
Absolute and percentage change of microalbuminuria
2 years
Absolute and percentage change of HbA1c
Time Frame: 2 years
Absolute and percentage change of HbA1c
2 years
Absolute and percentage change of NT-proBNP
Time Frame: 2 years
Absolute and percentage change of NT-proBNP
2 years
Absolute and percentage change of BMI
Time Frame: 2 years
Absolute and percentage change of BMI
2 years
Absolute and percentage change of body weight
Time Frame: 2 years
Absolute and percentage change of body weight
2 years
Changes in echocardiograhic parameters
Time Frame: 1 year
LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E'
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Myocardial Infarction

Clinical Trials on SGLT2 inhibitor

Subscribe