Empagliflozin for Reducing the Risk of No-Reflow Phenomenon in Patients Undergoing Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Non-Reflow Phenomenon
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Empagliflozin 10 Mg (Drug)
Standar Treatment
The patients included in this group will receive standar treatment according to the current guidelines
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.
干预措施: Empagliflozin 25 milgrams (Mg) (Drug)
结局指标
主要结局
Non-Reflow Phenomenon
时间窗: 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.
次要结局
- Longitudinal Strain(24 hours after the loading dose)
- High-sensitivity Troponin Clearance(72 hours after the loading dose)
- Infract size(72 hours after the loading dose)
- Creatine Kinase-myocardial band Clearance(72 hours after the loading dose)
- Adverse Cardiovascular Events(Up to 3 months after the loading dose)