Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Myocardial infarction remains, in our current era, a leading cause of morbidity and mortality both domestically and globally. A significant contributor to this issue is reperfusion injury, which enlarges the infarction, deteriorates ventricular function, leads to poorer outcomes, and currently has no specific treatment. Originally developed as an antidiabetic, empagliflozin has shown significant benefits in other organs and systems. Recent years have seen the demonstration of its cellular and vascular effects in animal models, potentially contributing to the reduction of reperfusion damage. However, no human studies have yet confirmed these effects. Consequently, this randomized, parallel-arm clinical trial was designed to evaluate the effect of empagliflozin treatment, administered from the pre-intervention period through to 3 days post-intervention, on the incidence of the no-reflow phenomenon in patients with ST-segment elevation myocardial infarction (STEMI) undergoing coronary angioplasty compared to a placebo. Before entering the hemodynamics room, participants in the intervention group will receive a loading dose of 25 mg of empagliflozin or a standar treatment. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group. Patients will be monitored weekly during the first month and bi-weekly during the second and third months. The primary outcome will be the incidence of the no-reflow phenomenon, measured through the Thrombolysis in Myocardial infarction (TIMI) flow scale in the coronary angiography performed to treat the infarction. Secondary outcomes will include the reduction of ST segment on the electrocardiogram, troponin levels, differences in the longitudinal strain by echocardiogram, and infarct size by magnetic resonance imaging.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• Acute myocardial infarction with ST-segment elevation

• Presentation to the institute within 12 hours of symptom onset

• Coronary angioplasty chosen as the reperfusion treatment for the subject

• Known diagnosis of diabetes or admission glucose \>180 mg/dl.

• Informed consent signed

Locations
Other Locations
Mexico
National Institute of Cardiology
RECRUITING
Mexico City
Contact Information
Primary
Fabio Solis-Jimenez, MD, MSc
fabiosolisjimenez@gmail.com
+525540838443
Time Frame
Start Date: 2024-08-22
Estimated Completion Date: 2025-10-15
Participants
Target number of participants: 162
Treatments
Experimental: Empagliflozin
The patients included in this group will receive a loading dose of 25 mg of Empagliflozin at the time of enrollment in the study, prior to percutaneous coronary intervention. Over the following three days, they will receive a daily maintenance dose of 10 mg of Empagliflozin.
No_intervention: Standar Treatment
The patients included in this group will receive standar treatment according to the current guidelines
Sponsors
Leads: Instituto Nacional de Cardiologia Ignacio Chavez

This content was sourced from clinicaltrials.gov