Myocardial InfarctionRECORD-AMINCT05770687
SGLT2 Inhibitors on Clinical Outcomes and Left Ventricular Remodeling in Type 2 Diabetic Patients with Acute Myocardial Infarction, a Prospective, Multi-center Registry Study
An observational study of Myocardial Infarction and Diabetes Mellitus, Type 2, run by Kiyuk Chang at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Myocardial Infarction, Diabetes Mellitus, Type 2
- What is being tested?
- SGLT2 inhibitor
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction
Who may be able to join
- Acute myocardial infarction who were treated with percutaneous coronary intervention
- Type 2 diabetes mellitus
- Started SGLT2 inhibitors <1 month before/after PCI
Who cannot join
- Type 1 diabetes mellitus
- Insulin / GLP-1 analogue users
- Previous users of SGLT2 inhibitors
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul St. Mary's Hospital
Seoul
Kiyuk Chang, kiyuk@catholic.ac.kr
About this 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
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.
Read the 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.
- Conditions
- Myocardial Infarction, Diabetes Mellitus, Type 2
- Being tested
- SGLT2 inhibitor
- Keywords
- Percutaneous Coronary Intervention, SGLT-2 inhibitor
- Medical subject headings
- Myocardial Infarction, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Also called dapagliflozin, empagliflozin, ertugliflozin, ipragliflozin
Patients started on SGLT2 inhibitors after PCI for AMI
| Study group | Role | What they receive |
|---|---|---|
| SGLT-2 inhibitor | Patients with naive use of SGLT-2 inhibitors after PCI Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac and cerebrovascular events
A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization
Measured: 2 years
Secondary outcomes (14)
Cardiac death
Cardiovascular death
Measured: 2 years
Nonfatal myocardial infarction
non-fatal myocardial infarction
Measured: 2 years
Nonfatal stroke
non-fatal stroke
Measured: 2 years
Hospitalization for heart failure
hospitalization for HF
Measured: 2 years
Target lesion revascularization
Revascularization performed for target lesion
Measured: 2 years
Target vessel revascularization
Revascularization performed for target vessel
Measured: 2 years
Non-target vessel revascularization
Revascularization performed for non-target vessel
Measured: 2 years
Definite/Probable stent thrombosis
Definite or probable stent thrombosis
Measured: 2 years
Absolute and percentage change of microalbuminuria
Absolute and percentage change of microalbuminuria
Measured: 2 years
Absolute and percentage change of HbA1c
Absolute and percentage change of HbA1c
Measured: 2 years
Absolute and percentage change of NT-proBNP
Absolute and percentage change of NT-proBNP
Measured: 2 years
Absolute and percentage change of BMI
Absolute and percentage change of BMI
Measured: 2 years
Absolute and percentage change of body weight
Absolute and percentage change of body weight
Measured: 2 years
Changes in echocardiograhic parameters
LVEF, LVEDV, LVESV, LVMI, E, A, DT, E/E'
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Aug 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kiyuk Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Incheon St.Mary's Hospital, Daejeon St. Mary's hospital, Bucheon St. Mary's Hospital, St Vincent's Hospital, Yeouido St. Mary's Hospital, Sejong General Hospital, Pusan National University Hospital, Andong Hospital, Chungnam National University Hospital, St. Carollo General Hospital, Pusan National University Yangsan Hospital, Kyungpook National University Hospital, Jeju National University Hospital, Korea University Anam Hospital, Inje University
- Responsible party
- Sponsor-investigator, Kiyuk Chang, Seoul St. Mary's Hospital
- Investigators
- Kiyuk Chang, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770687
- Sponsor's protocol ID
- KC19OEDI0591
- Acronym
- RECORD-AMI
- Status last verified
- Jan 2025
- First submitted
- 5 Mar 2023
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05770687
- Acronym / sponsor ID
- RECORD-AMI / KC19OEDI0591
- Conditions
- Myocardial Infarction, Diabetes Mellitus, Type 2
- Keywords
- Percutaneous Coronary Intervention, SGLT-2 inhibitor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kiyuk ChangUniversity, hospital or other
- Collaborators
- Seoul St. Mary's Hospital, Uijeongbu St. Mary Hospital, Incheon St.Mary's Hospital, Daejeon St. Mary's hospital, Bucheon St. Mary's Hospital, St Vincent's Hospital, Yeouido St. Mary's Hospital, Sejong General Hospital, Pusan National University Hospital, Andong Hospital, Chungnam National University Hospital, St. Carollo General Hospital, Pusan National University Yangsan Hospital, Kyungpook National University Hospital, Jeju National University Hospital, Korea University Anam Hospital, Inje University
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SGLT-2 inhibitor | – | Drug: SGLT2 inhibitorPatients with naive use of SGLT-2 inhibitors after PCI |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes mellitus patients undergoing percutaneous coronary intervention for acute myocardial infarction
Key inclusion criteria (3 listed)
- Acute myocardial infarction who were treated with percutaneous coronary intervention
- Type 2 diabetes mellitus
- Started SGLT2 inhibitors <1 month before/after PCI
Key exclusion criteria (4 listed)
- Type 1 diabetes mellitus
- Insulin / GLP-1 analogue users
- Previous users of SGLT2 inhibitors
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorAlso: dapagliflozin, empagliflozin, ertugliflozin, ipragliflozinPatients started on SGLT2 inhibitors after PCI for AMI | Drug | SGLT-2 inhibitor |
Primary outcome
Major adverse cardiac and cerebrovascular events
Time frame: 2 years
A composite of cardiac death, nonfatal MI, nonfatal stroke, and HF hospitalization
14 secondary outcomes
Cardiac death
Time frame: 2 years
Nonfatal myocardial infarction
Time frame: 2 years
Nonfatal stroke
Time frame: 2 years
Hospitalization for heart failure
Time frame: 2 years
Target lesion revascularization
Time frame: 2 years
Target vessel revascularization
Time frame: 2 years
Non-target vessel revascularization
Time frame: 2 years
Definite/Probable stent thrombosis
Time frame: 2 years
Absolute and percentage change of microalbuminuria
Time frame: 2 years
Absolute and percentage change of HbA1c
Time frame: 2 years
Absolute and percentage change of NT-proBNP
Time frame: 2 years
Absolute and percentage change of BMI
Time frame: 2 years
Absolute and percentage change of body weight
Time frame: 2 years
Changes in echocardiograhic parameters
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kiyuk Chang, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction and Diabetes Mellitus, Type 2, run by Kiyuk Chang at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kiyuk Chang, MD, PhD (82-2-2258-1139, kiyuk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac and cerebrovascular events (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.