Epicardial Cardiac Fat-CT (EPIC-CT)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstituto Mexicano del Seguro Social

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dapagliflozin 10 MG Oral Tablet

    Drug

    10 mg of dapagliflozin daily for 12 months

  • Semaglutide (Rybelsus®)

    Drug

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

Treatment groups

136 Participants
are divided into 2 treatment groups
Group A: DapagliflozinExperimental treatment 1 intervention
Group B: SemaglutideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Epicardial fat

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.

Time frame
12 months

Secondary outcomes

1

Change in LDL

The effect of both interventions on LDL levels after 12 months of treatment will be evaluated.

Time frame
12 months
2

Change in fasting glucose and HbA1c

The impact of both interventions on changes in fasting glucose and HbA1c after 12 months of treatment will be assessed.

Time frame
12 months
3

Major adverse cardiovascular events (MACE)

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.

Time frame
12 months
4

Change in body weight

The effect of both interventions on body weight, expressed in kilograms, will be evaluated after 12 months of treatment.

Time frame
12 months

Other outcomes

Sponsors and contacts

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