protocolSection identificationModule nctId: NCT06342141, orgStudyIdInfo id: 24-1423, briefTitle: Empagliflozin for No-reflow Phenomenon in PCI for STEMI, acronym: EMPA-PCI, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Instituto Nacional de Cardiologia Ignacio Chavez, class: OTHER, descriptionModule briefSummary: 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 double-blind, 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 placebo. In-hospital treatment will continue with 10 mg empagliflozin daily for 3 days for the intervention group, while the control group will receive a placebo. 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., conditionsModule conditions: STEMI, conditions: No-Reflow Phenomenon, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 162, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 25 milgrams (Mg), interventions name: Empagliflozin 10 Mg, interventions name: Placebo 25 Mg, interventions name: Placebo 10 Mg, outcomesModule primaryOutcomes measure: Non-Reflow Phenomenon, secondaryOutcomes measure: Infract size, secondaryOutcomes measure: Longitudinal Strain, secondaryOutcomes measure: High-sensitivity Troponin Clearance, secondaryOutcomes measure: Creatine Kinase-myocardial band Clearance, secondaryOutcomes measure: Adverse Cardiovascular Events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False