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NCT Number: 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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Heart Diseases Infarction Ischemia Metabolic Diseases Myocardial Ischemia Necrosis Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul St. Mary's Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Kiyuk Chang

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGLT2 inhibitor

Drug

Patients started on SGLT2 inhibitors after PCI for AMI

Other names: dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin

Primary outcomes

  1. Major adverse cardiac and cerebrovascular events

    Time frame: 2 years

    A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization

Secondary outcomes

  1. Cardiac death

    Time frame: 2 years

    Cardiovascular death

  2. Nonfatal myocardial infarction

    Time frame: 2 years

    non-fatal myocardial infarction

  3. Nonfatal stroke

    Time frame: 2 years

    non-fatal stroke

  4. Hospitalization for heart failure

    Time frame: 2 years

    hospitalization for HF

  5. Target lesion revascularization

    Time frame: 2 years

    Revascularization performed for target lesion

  6. Target vessel revascularization

    Time frame: 2 years

    Revascularization performed for target vessel

  7. Non-target vessel revascularization

    Time frame: 2 years

    Revascularization performed for non-target vessel

  8. Definite/Probable stent thrombosis

    Time frame: 2 years

    Definite or probable stent thrombosis

  9. Absolute and percentage change of microalbuminuria

    Time frame: 2 years

    Absolute and percentage change of microalbuminuria

  10. Absolute and percentage change of HbA1c

    Time frame: 2 years

    Absolute and percentage change of HbA1c

  11. Absolute and percentage change of NT-proBNP

    Time frame: 2 years

    Absolute and percentage change of NT-proBNP

  12. Absolute and percentage change of BMI

    Time frame: 2 years

    Absolute and percentage change of BMI

  13. Absolute and percentage change of body weight

    Time frame: 2 years

    Absolute and percentage change of body weight

  14. Changes in echocardiograhic parameters

    Time frame: 1 year

    LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E'

Study contacts

Contact information is provided by the study sponsor or research team.

Kiyuk Chang, MD, PhD

CONTACT

[email protected]

82-2-2258-1139

Sponsors and collaborators

Lead sponsor

Kiyuk Chang

Other

Collaborators

  • 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

Registry information

Official study 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

Acronym: RECORD-AMI

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 15, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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