NCT07297589 Epicardial Cardiac Fat-CT (EPIC-CT)
| NCT ID | NCT07297589 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Instituto Mexicano del Seguro Social |
| Condition | STEMI - ST Elevation Myocardial Infarction |
| Study Type | INTERVENTIONAL |
| Enrollment | 136 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 136 participants in total. It began in 2025-12-30 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Rodolfo Guardado-Mendoza, Ph.D.
STUDY CHAIR
Universidad de Guanajuato
Frequently Asked Questions
Who can join the NCT07297589 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying STEMI - ST Elevation Myocardial Infarction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07297589 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 136 participants.
Is NCT07297589 currently recruiting?
Yes, NCT07297589 is actively recruiting participants. Contact the research team at hildamacer@gmail.com for enrollment information.
Where is the NCT07297589 trial being conducted?
This trial is being conducted at León, Mexico.
Who is sponsoring the NCT07297589 clinical trial?
NCT07297589 is sponsored by Instituto Mexicano del Seguro Social. The principal investigator is Rodolfo Guardado-Mendoza, Ph.D. at Universidad de Guanajuato. The trial plans to enroll 136 participants.