Myocardial InfarctionNCT06245980
Role of SGLT2I in Patients With Myocardial Infarction
An observational study of Myocardial Infarction and Diabetes Mellitus, run by Dongying Zhang at 1 site in China.
Trial summary
Role of sglt2I in diabetic patients with myocardial infarction Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction, Diabetes Mellitus
- What is being tested?
- SGLT2 inhibitor
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute myocardial infarction patients with diabetes mellitus
Who may be able to join
- Acute myocardial infarction patients
- Type 2 diabetics.
Who cannot join
- Patients undergoing coronary artery bypass grafting (CABG).
- Severe valvular heart disease.
- Contraindications of secondary medical preventive therapy for myocardial infarction, such as β-blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin-converting enzyme inhibitors (ARBs), antiplatelets, and statins.
- Previously used SGLT2i.
- Severe hepatic and renal insufficiency.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
xuesong wen, doctor, 18702384027, 1979272415@qq.com
About this study
Official title: Role of SGLT2I in Diabetic Patients With Myocardial Infarction
Role of sglt2I in diabetic patients with myocardial infarction
- Conditions
- Myocardial Infarction, Diabetes Mellitus
- Being tested
- SGLT2 inhibitor
- Medical subject headings
- Myocardial Infarction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
According to whether SGLT2i was used
| Study group | Role | What they receive |
|---|---|---|
| With SGLT2I | Not described Receives: Drug: SGLT2 inhibitor | |
| Without SGLT2i | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
cardiovascular death and heart failure and myocardial infarction
Measured: 24months
Heart failure readmission
Heart failure readmission
Measured: 24months
Secondary outcomes (2)
Recurrent myocardial infarction
Recurrent myocardial infarction
Measured: 24months
cardiovascular death
cardiovascular death
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Jan 2018
- Primary completion28 Feb 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongying Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dongying Zhang, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245980
- Sponsor's protocol ID
- 20230515
- Status last verified
- May 2023
- First submitted
- 30 Jan 2024
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Luo S, Liu H, Li Z, Zhou Y, He S, Zhang D, Qin S, Wen X. Effects of SGLT2 Inhibitor in Patients with Diabetes with Newly Diagnosed Acute Myocardial Infarction: A Multicenter Prospective Cohort Study. Cardiovasc Drugs Ther. 2026 Apr;40(2):543-554. doi: 10.1007/s10557-025-07716-y. Epub 2025 May 22.
PubMed 40402390
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of SGLT2I in Diabetic Patients With Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06245980
- Acronym / sponsor ID
- 20230515
- Conditions
- Myocardial Infarction, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Dongying ZhangUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 28 Feb 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 7 Feb 2024 (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.
Role of sglt2I in diabetic patients with myocardial infarction
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With SGLT2I | – | Drug: SGLT2 inhibitor |
| Without SGLT2i | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute myocardial infarction patients with diabetes mellitus
Key inclusion criteria (2 listed)
- Acute myocardial infarction patients
- Type 2 diabetics.
Key exclusion criteria (5 listed)
- Patients undergoing coronary artery bypass grafting (CABG).
- Severe valvular heart disease.
- Contraindications of secondary medical preventive therapy for myocardial infarction, such as β-blockers, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin-converting enzyme inhibitors (ARBs), antiplatelets, and statins.
- Previously used SGLT2i.
- Severe hepatic and renal insufficiency.
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 inhibitorAccording to whether SGLT2i was used | Drug | With SGLT2I |
Primary outcome
MACE
Time frame: 24months
cardiovascular death and heart failure and myocardial infarction
Heart failure readmission
Time frame: 24months
Heart failure readmission
2 secondary outcomes
Recurrent myocardial infarction
Time frame: 24months
cardiovascular death
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 40402390Luo S, Liu H, Li Z, Zhou Y, He S, Zhang D, Qin S, Wen X. Effects of SGLT2 Inhibitor in Patients with Diabetes with Newly Diagnosed Acute Myocardial Infarction: A Multicenter Prospective Cohort Study. Cardiovasc Drugs Ther. 2026 Apr;40(2):543-554. doi: 10.1007/s10557-025-07716-y. Epub 2025 May 22.
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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. This study is not recruiting at the moment.
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, run by Dongying Zhang at 1 site in China.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2024. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuesong wen (+8618702384027, 1979272415@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 24months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06245980, which also lists 1 linked publication.
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 8 Feb 2024.