Epicardial Cardiac Fat-CT (EPIC-CT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dapagliflozin 10 MG Oral Tablet, Semaglutide (Rybelsus®).
- Who it may be relevant to
- Registry conditions: STEMI - ST Elevation Myocardial Infarction, Epicardial Fat. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Mexico
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Epicardial Cardiac Fat Comparative Trial
Overview
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
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.
Interventions
- Drug Dapagliflozin 10 MG Oral Tablet
10 mg of dapagliflozin daily for 12 months - Drug Semaglutide (Rybelsus®)
Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months
Primary outcome measures
- Epicardial fat [Time frame: 12 months]
Secondary outcome measures (4)
- Change in LDL [Time frame: 12 months]
- Change in fasting glucose and HbA1c [Time frame: 12 months]
- Major adverse cardiovascular events (MACE) [Time frame: 12 months]
- Change in body weight [Time frame: 12 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Mexico · 1 center
- Unidad Medica de Alta Especialidad No. 1, Bajío — León
Identifiers
NCT: NCT07297589 · R-2025-1001-087