NCT06245980

Brief Summary

Role of sglt2I in diabetic patients with myocardial infarction

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 8, 2024

Status Verified

May 1, 2023

Enrollment Period

6.2 years

First QC Date

January 30, 2024

Last Update Submit

February 7, 2024

Conditions

Myocardial InfarctionDiabetes Mellitus

Outcome Measures

Primary Outcomes (2)

  • MACE

    cardiovascular death and heart failure and myocardial infarction

    24months

  • Heart failure readmission

    Heart failure readmission

    24months

Secondary Outcomes (2)

  • Recurrent myocardial infarction

    24months

  • cardiovascular death

    24months

Study Arms (2)

With SGLT2I

Drug: SGLT2 inhibitor

Without SGLT2i

Interventions

SGLT2 inhibitorDRUG

According to whether SGLT2i was used

With SGLT2I

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute myocardial infarction patients with diabetes mellitus

You may qualify if:

  • Acute myocardial infarction patients
  • Type 2 diabetics.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (1)

  • 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. 2025 May 22. doi: 10.1007/s10557-025-07716-y. Online ahead of print.

    PMID: 40402390DERIVED

MeSH Terms

Conditions

Myocardial InfarctionDiabetes Mellitus

Interventions

Sodium-Glucose Transporter 2 Inhibitors

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHypoglycemic AgentsPhysiological Effects of Drugs

Central Study Contacts

xuesong wen

CONTACT

+86187023840271979272415@qq.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

January 1, 2018

Primary Completion

February 28, 2024

Study Completion

March 31, 2024

Last Updated

February 8, 2024

Record last verified: 2023-05

Locations

CN(1)