Epicardial Cardiac Fat-CT (EPIC-CT)

Официальное название

Epicardial Cardiac Fat Comparative Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Dapagliflozin 10 MG Oral Tablet
  10 mg of dapagliflozin daily for 12 months
• Препарат Semaglutide (Rybelsus®)
  Semaglutide 3 mg, gradually increasing to 14 mg every 24 hours for 12 months

Первичные конечные точки

• Epicardial fat [Срок оценки: 12 months]

Вторичные конечные точки (4)

• Change in LDL [Срок оценки: 12 months]
• Change in fasting glucose and HbA1c [Срок оценки: 12 months]
• Major adverse cardiovascular events (MACE) [Срок оценки: 12 months]
• Change in body weight [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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%.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Unidad Medica de Alta Especialidad No. 1, Bajío — León

Идентификаторы

NCT: NCT07297589 · R-2025-1001-087

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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