Epicardial Cardiac Fat-CT (EPIC-CT) (EPIC-CT)

December 30, 2025 updated by: Hilda Elizabeth Macías Cervantes, Instituto Mexicano del Seguro Social

Epicardial Cardiac Fat Comparative Trial

Both globally and nationally, heart disease remains the leading cause of death overall and across genders, with ischemic heart disease being the primary cause. It is now understood that multiple risk factors contribute to the development of this condition, notably type 2 diabetes mellitus and obesity, especially an increase in visceral fat. Among these, the role of epicardial fat volume in the presence of atheromatous plaques in patients with coronary artery disease has been emphasized, along with the link between its volume and the risk of ischemic cardiovascular events. Consequently, recent decades have seen focused research on the potential of epicardial fat as a marker for major adverse cardiac events and on strategies to reduce its volume as a treatment goal for patients with risk factors.

Selective sodium-glucose cotransporter 2 inhibitors are drugs that, beyond their antihyperglycemic effect, have demonstrated cardiovascular benefits through various mechanisms, including a reduction in epicardial fat. This was supported by a previous study conducted by our research group, although no statistically significant difference was found. On the other hand, GLP-1 agonists are effective drugs for weight control in patients with severe obesity. However, little research has been done on their effect on more localized fat, such as epicardial fat.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, open-label clinical trial will assess the effects of dapagliflozin compared to semaglutide on epicardial fat in patients with ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction over a 12-month period. Epicardial fat will be measured by simple coronary tomography during initial hospitalization for infarction and after 12 months of treatment with both medications.

It will include patients over 18 years old with STEMI and NSTEMI, with or without a diagnosis of type 2 diabetes and clinical obesity. Patients will be discharged following treatment guidelines, and their adherence to medication and tolerability will be monitored.

Study Type

Interventional

Enrollment (Estimated)

136

Phase

  • Phase 3

Contacts and Locations

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

Study Contact

  • Name: Hilda Elizabeth Macías-Cervantes, Ph.D.
  • Phone Number: 31315 4777174800
  • Email: hildamacer@gmail.com

Study Contact Backup

  • Name: Rodolfo Guardado-Mendoza, Ph.D.
  • Phone Number: 3683 4772674900
  • Email: guardamen@gmail.com

Study Locations

  • Mexico
    • Guanajuato
      • León, Guanajuato, Mexico, 37260,
        • Recruiting
        • Unidad Medica de Alta Especialidad No. 1, Bajío
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Criteria for the fourth definition of acute myocardial infarction with and without ST-segment elevation.

    • Diagnosed with type 2 diabetes.
    • Initial serum high-sensitivity CRP value > 2.0 mg/L.
    • Clinically obese.
    • LVEF >50%.

Exclusion Criteria:

  • Patients who have recently received immunosuppressive therapy
  • Patients with a history of ischemic heart disease
  • Known allergy to any of the medications used
  • Use of any of the study drugs more than 6 months prior to randomization
  • Patients experiencing diabetic ketoacidosis
  • Patients with hemodynamic instability (mean arterial pressure <60 mmHg while on vasopressors)
  • Pregnant women
  • Patients with a history or current diagnosis of cancer
  • Patients with documented active infections, such as pneumonia or urinary tract infections
  • Patients with pancreatitis

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dapagliflozin
Dapagliflozin 10 mg daily
Drug: Dapagliflozin 10 MG Oral Tablet
10 mg of dapagliflozin daily for 12 months
Active Comparator: Semaglutide
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours
Drug: Semaglutide (Rybelsus®)
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epicardial fat
Time Frame: 12 months
The volume of epicardial fat will be measured using simple coronary tomography during hospitalization for STEMI and after 12 months of treatment with both drugs to evaluate the change.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in LDL
Time Frame: 12 months
The effect of both interventions on LDL levels after 12 months of treatment will be evaluated.
12 months
Change in fasting glucose and HbA1c
Time Frame: 12 months
The impact of both interventions on changes in fasting glucose and HbA1c after 12 months of treatment will be assessed.
12 months
Major adverse cardiovascular events (MACE)
Time Frame: 12 months
During patient follow-up, the occurrence of cardiac failure events, whether requiring hospitalization or not, along with new acute myocardial infarction, cardiovascular death, or stroke, will be evaluated.
12 months
Change in body weight
Time Frame: 12 months
The effect of both interventions on body weight, expressed in kilograms, will be evaluated after 12 months of treatment.
12 months

Collaborators and Investigators

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

Sponsor

Instituto Mexicano del Seguro Social

Investigators

  • Study Chair: Rodolfo Guardado-Mendoza, Ph.D., Universidad de Guanajuato

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)

December 30, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Estimated)

December 22, 2025

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2025-1001-087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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