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Epicardial Cardiac Fat-CT (EPIC-CT)

NCT ID: NCT07297589

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-30

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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STEMI - ST Elevation Myocardial Infarction Epicardial Fat

Keywords

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Epicardial fat STEMI Semaglutide Dapagliflozin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Dapagliflozin

Dapagliflozin 10 mg daily

Group Type EXPERIMENTAL

Dapagliflozin 10 MG Oral Tablet

Intervention Type DRUG

10 mg of dapagliflozin daily for 12 months

Semaglutide

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours

Group Type ACTIVE_COMPARATOR

Semaglutide (Rybelsus®)

Intervention Type DRUG

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

Interventions

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Dapagliflozin 10 MG Oral Tablet

10 mg of dapagliflozin daily for 12 months

Intervention Type DRUG

Semaglutide (Rybelsus®)

Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Mexicano del Seguro Social

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hilda Elizabeth Macías Cervantes

Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rodolfo Guardado-Mendoza, Ph.D.

Role: STUDY_CHAIR

Universidad de Guanajuato

Locations

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Unidad Medica de Alta Especialidad No. 1, Bajío

León, Guanajuato, Mexico

Site Status

Countries

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Mexico

Central Contacts

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Hilda Elizabeth Macías-Cervantes, Ph.D.

Role: CONTACT

Phone: 4777174800

Email: [email protected]

Rodolfo Guardado-Mendoza, Ph.D.

Role: CONTACT

Phone: 4772674900

Email: [email protected]

Other Identifiers

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R-2025-1001-087

Identifier Type: -

Identifier Source: org_study_id