Clinical trial

Epicardial Cardiac Fat-CT (EPIC-CT)

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07297589

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionSTEMI - ST Elevation Myocardial Infarction, Epicardial Fat

Full registry criteria

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

Treatments and study arms

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

Primary outcomes

Epicardial fat12 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Unidad Medica de Alta Especialidad No. 1, Bajío🇲🇽 León, Guanajuato, Mexico

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Hilda E Macias Cervantes, master in clinical researchContact