No-Reflow Phenomenon, STEMI
Conditions
Brief 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.
Interventions
DRUGEmpagliflozin 25 milgrams (Mg)
Load dose
DRUGEmpagliflozin 10 Mg
Maintenance dose
Sponsors
Instituto Nacional de Cardiologia Ignacio Chavez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Hemodynamically unstable subjects * Subjects undergoing thrombolysis treatment in the current event * History of coronary revascularization surgery * Known allergy or hypersensitivity to Sodium-glucose co-transporter-2 (SGLT2) inhibitors * History of recurrent urinary tract infections * Known chronic kidney disease and estimated glomerular filtration rate (eGFR) \< 20 * Ongoing treatment with any SGLT2 inhibitor * Participation in another clinical trial or having participated in the week prior to recruitment * For women of childbearing age: Current or planned pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-Reflow Phenomenon | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infract size | 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. |
| Longitudinal Strain | 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. |
| High-sensitivity Troponin Clearance | 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. |
| Creatine Kinase-myocardial band Clearance | 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. |
| Adverse Cardiovascular Events | 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. |
Countries
Mexico
Contacts
PRINCIPAL_INVESTIGATOREduardo Arias-Sanchez, MD
Deputy Head of the Department of Interventional Cardiology at the National Institute of Cardiology
Outcome results
None listed