National Institute of Cardiology
Mexico City, 14080, Mexico
NCT Number: NCT06342141
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–85 year
All sexes
Interventional
Phase 2
Mexico City, 14080, Mexico
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Load dose
Other names: Jardiance 25 Mg
Maintenance dose
Other names: Jardiance 10 Mg
Time frame: During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose)
Incidence of non-reflow phenomenon during percutaneous coronary intervention measured using the Thrombolysis in myocardial infarction (TIMI) Flow Grading System. Dichotomous variable (yes/no).
The TIMI flow grading system ranges from 0 to 3. Grade 3 flow is the best result of angioplasty and means that flow has been restored to normal. Grade 2 flow means that the contrast flows throughout the entire artery but more slowly than normal. Grade 1 flow means that the contrast flows through the artery but does not reach the end of the artery. Flow grade 0 means that contrast does not flow in the artery. It is the worst result of an angiography. Any flow other than grade 3 is interpreted as a non-reflow phenomenon.
Time frame: 72 hours after the loading dose
Myocardial infarct size measured in grams using cardiac magnetic resonance. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
Time frame: 24 hours after the loading dose
Longitudinal Strain measured in percentage using transthoracic echocardiogram. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
Time frame: 72 hours after the loading dose
Percentage of High-sensitivity troponin decrease when comparing admission values with values at 72 hours. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
Time frame: 72 hours after the loading dose
Percentage of creatine kinase-myocardial band (CK-MB) decrease when comparing admission values with values at 72 hours. Continuous variable. Mean difference between both groups. This outcome will not be combined with other secondary outcomes.
Time frame: Up to 3 months after the loading dose
Incidence of Rehospitalization, malignant arrhythmias, cardiogenic shock, reinfarction, urgent revascularization, death. This outcome will not be combined with other secondary outcomes.
Instituto Nacional de Cardiologia Ignacio Chavez
Other
Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction
Acronym: EMPA-PCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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