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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Empagliflozin | Experimental | 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. |
|
| Standar Treatment | No Intervention | The patients included in this group will receive standar treatment according to the current guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Empagliflozin 25 milgrams (Mg) | Drug | Load dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Non-Reflow Phenomenon | 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. | During percutaneous coronary intervention (approximately 60 minutes after receiving the loading dose) |
| Measure | Description | Time Frame |
|---|---|---|
| Infract size | 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. | 72 hours after the loading dose |
| Longitudinal Strain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Arias-Sanchez, MD | Deputy Head of the Department of Interventional Cardiology at the National Institute of Cardiology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiology | Mexico City | Mexico City | 14080 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20837571 | Background | Niccoli G, Kharbanda RK, Crea F, Banning AP. No-reflow: again prevention is better than treatment. Eur Heart J. 2010 Oct;31(20):2449-55. doi: 10.1093/eurheartj/ehq299. Epub 2010 Sep 13. No abstract available. | |
| 31026233 | Background | Tasar O, Karabay AK, Oduncu V, Kirma C. Predictors and outcomes of no-reflow phenomenon in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention. Coron Artery Dis. 2019 Jun;30(4):270-276. doi: 10.1097/MCA.0000000000000726. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D054318 | No-Reflow Phenomenon |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| Empagliflozin 10 Mg | Drug | Maintenance 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. |
| 24 hours after the loading dose |
| High-sensitivity Troponin Clearance | 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. | 72 hours after the loading dose |
| Creatine Kinase-myocardial band Clearance | 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. | 72 hours after the loading dose |
| Adverse Cardiovascular Events | Incidence of Rehospitalization, malignant arrhythmias, cardiogenic shock, reinfarction, urgent revascularization, death. This outcome will not be combined with other secondary outcomes. | Up to 3 months after the loading dose |
| 19608025 | Background | Niccoli G, Burzotta F, Galiuto L, Crea F. Myocardial no-reflow in humans. J Am Coll Cardiol. 2009 Jul 21;54(4):281-92. doi: 10.1016/j.jacc.2009.03.054. |
| 35456326 | Background | Annibali G, Scrocca I, Aranzulla TC, Meliga E, Maiellaro F, Musumeci G. "No-Reflow" Phenomenon: A Contemporary Review. J Clin Med. 2022 Apr 16;11(8):2233. doi: 10.3390/jcm11082233. |
| 30992077 | Result | Sayour AA, Korkmaz-Icoz S, Loganathan S, Ruppert M, Sayour VN, Olah A, Benke K, Brune M, Benko R, Horvath EM, Karck M, Merkely B, Radovits T, Szabo G. Acute canagliflozin treatment protects against in vivo myocardial ischemia-reperfusion injury in non-diabetic male rats and enhances endothelium-dependent vasorelaxation. J Transl Med. 2019 Apr 16;17(1):127. doi: 10.1186/s12967-019-1881-8. |
| 31127491 | Result | Cooper S, Teoh H, Campeau MA, Verma S, Leask RL. Empagliflozin restores the integrity of the endothelial glycocalyx in vitro. Mol Cell Biochem. 2019 Sep;459(1-2):121-130. doi: 10.1007/s11010-019-03555-2. Epub 2019 May 24. |
| 32539724 | Result | Lahnwong C, Palee S, Apaijai N, Sriwichaiin S, Kerdphoo S, Jaiwongkam T, Chattipakorn SC, Chattipakorn N. Acute dapagliflozin administration exerts cardioprotective effects in rats with cardiac ischemia/reperfusion injury. Cardiovasc Diabetol. 2020 Jun 15;19(1):91. doi: 10.1186/s12933-020-01066-9. |
| 31779619 | Result | Shao Q, Meng L, Lee S, Tse G, Gong M, Zhang Z, Zhao J, Zhao Y, Li G, Liu T. Empagliflozin, a sodium glucose co-transporter-2 inhibitor, alleviates atrial remodeling and improves mitochondrial function in high-fat diet/streptozotocin-induced diabetic rats. Cardiovasc Diabetol. 2019 Nov 28;18(1):165. doi: 10.1186/s12933-019-0964-4. |
| 32396609 | Result | Kolijn D, Pabel S, Tian Y, Lodi M, Herwig M, Carrizzo A, Zhazykbayeva S, Kovacs A, Fulop GA, Falcao-Pires I, Reusch PH, Linthout SV, Papp Z, van Heerebeek L, Vecchione C, Maier LS, Ciccarelli M, Tschope C, Mugge A, Bagi Z, Sossalla S, Hamdani N. Empagliflozin improves endothelial and cardiomyocyte function in human heart failure with preserved ejection fraction via reduced pro-inflammatory-oxidative pathways and protein kinase Galpha oxidation. Cardiovasc Res. 2021 Jan 21;117(2):495-507. doi: 10.1093/cvr/cvaa123. |
| 31759100 | Result | Lu Q, Liu J, Li X, Sun X, Zhang J, Ren D, Tong N, Li J. Empagliflozin attenuates ischemia and reperfusion injury through LKB1/AMPK signaling pathway. Mol Cell Endocrinol. 2020 Feb 5;501:110642. doi: 10.1016/j.mce.2019.110642. Epub 2019 Nov 21. |
| 34712142 | Result | Tan Y, Yu K, Liang L, Liu Y, Song F, Ge Q, Fang X, Yu T, Huang Z, Jiang L, Wang P. Sodium-Glucose Co-Transporter 2 Inhibition With Empagliflozin Improves Cardiac Function After Cardiac Arrest in Rats by Enhancing Mitochondrial Energy Metabolism. Front Pharmacol. 2021 Oct 12;12:758080. doi: 10.3389/fphar.2021.758080. eCollection 2021. |
| 34896968 | Result | Uthman L, Li X, Baartscheer A, Schumacher CA, Baumgart P, Hermanides J, Preckel B, Hollmann MW, Coronel R, Zuurbier CJ, Weber NC. Empagliflozin reduces oxidative stress through inhibition of the novel inflammation/NHE/[Na+]c/ROS-pathway in human endothelial cells. Biomed Pharmacother. 2022 Feb;146:112515. doi: 10.1016/j.biopha.2021.112515. Epub 2021 Dec 9. |
| 32717242 | Result | Seo MS, Jung HS, An JR, Kang M, Heo R, Li H, Han ET, Yang SR, Cho EH, Bae YM, Park WS. Empagliflozin dilates the rabbit aorta by activating PKG and voltage-dependent K+ channels. Toxicol Appl Pharmacol. 2020 Sep 15;403:115153. doi: 10.1016/j.taap.2020.115153. Epub 2020 Jul 24. |
| 35705980 | Result | Zou R, Shi W, Qiu J, Zhou N, Du N, Zhou H, Chen X, Ma L. Empagliflozin attenuates cardiac microvascular ischemia/reperfusion injury through improving mitochondrial homeostasis. Cardiovasc Diabetol. 2022 Jun 15;21(1):106. doi: 10.1186/s12933-022-01532-6. |
| 41230400 | Derived | Solis-Jimenez F, Araiza-Garaygordobil D, Masso-Bueso JS, Villalobos-Ordaz A, Arellano-Juvera F, Arredondo-Aragon F, Melendez-Ramirez G, Valdez-Ortiz R, Alday-Ramirez SM, Rodriguez-Zanella HG, Amezcua Guerra LM, Arias-Mendoza MA, Martinez-Rios MA, Arias-Sanchez EA, Eid-Lidt G. Effect of empagliflozin on reducing the no-reflow phenomenon in patients with ST-elevation myocardial infarction: rationale and design of the EMPA-PCI trial. Eur Heart J Open. 2025 Oct 5;5(6):oeaf128. doi: 10.1093/ehjopen/oeaf128. eCollection 2025 Nov. |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |