Noninvasive Artificial Venous Stasis and Coronary Reperfusion in ST-Segment Elevation Myocardial Infarction:The RE-START STEMI Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Presence of Spontaneous Coronary Reperfusion Before Primary PCI
研究概览
简要总结
This prospective, randomized study was designed to evaluate whether the noninvasive artificial venous stasis / RE-START procedure, administered prior to primary percutaneous coronary intervention, increases the frequency of spontaneous coronary reperfusion in the infarct-related artery.
详细描述
The primary hypothesis of the study is that the application of short-term, controlled venous return restriction via a blood pressure cuff on the non-dominant arm may support thrombus lysis by stimulating endothelial-derived fibrinolytic activity and may increase the rate of spontaneous reperfusion, defined as TIMI 2 or TIMI 3 flow, in the infarct-related artery prior to primary percutaneous coronary intervention.
This study seeks to answer the following key question: In patients with acute STEMI, does the RE-START procedure-administered without delaying standard care or the preparation process for primary percutaneous coronary intervention-increase the incidence of spontaneous coronary reperfusion prior to primary percutaneous coronary intervention compared to a sham/control procedure?
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having presented within the first 12 hours of symptom onset Being hemodynamically stable (Killip Class I-II)
- •STEMI diagnosis confirmed by coronary angiography
- •Primary PCI (percutaneous coronary intervention) scheduled
- •No pathology in the upper extremity that would prevent cuff application
- •Be capable of providing informed consent and provide consent
排除标准
- •Presence of cardiogenic shock (systolic blood pressure < 90 mmHg and Killip Class III-IV)
- •Cardiac arrest occurring before or after the procedure
- •Need for resuscitation following failed thrombolysis
- •History of prior coronary artery bypass surgery
- •Concurrent acute aortic dissection
- •Venous thromboembolism or pulmonary embolism
- •History of an acute infection within the past 7 days
- •Chronic kidney disease requiring erythropoietin therapy or currently undergoing hemodialysis
- •Presence of liver failure or a hematologic disorder
- •Presence of any chronic inflammatory or autoimmune disease
- •History of any known malignancy (cancer)
- •Current treatment with glibenclamide, corticosteroids, antioxidant vitamins, or cyclosporine at the time of enrollment
- •History of chronic (daily) alcohol consumption
- •Contraindications to aspirin and/or clopidogrel
- •Failure to confirm a STEMI diagnosis via coronary angiography
- •Inability to provide informed consent
- •Pregnancy
- •First 6 months postpartum Conditions in which the administration of thrombolytics is contraindicated
结局指标
主要结局
Presence of Spontaneous Coronary Reperfusion Before Primary PCI
时间窗: Periprocedural
Spontaneous coronary reperfusion will be defined as the presence of TIMI flow grade 2 or 3 in the infarct-related artery on the first diagnostic coronary angiography performed before guidewire crossing and before primary percutaneous coronary intervention
次要结局
- ST-Segment Resolution After Primary PCI(90 minutes after primary PCI)
- Left Ventricular Ejection Fraction(Within 48 hours after primary PCI)
- Peak-to-Baseline D-Dimer Ratio Through Day 3(From baseline to Day 3 or hospital discharge, whichever occurs first)
- NT-proBNP Level at Hospital Discharge(At hospital discharge)
- Contrast-Associated Acute Kidney Injury(From baseline to 48-72 hours after primary PCI)
研究者
Mehmet BALİN
MD, Professor
Firat University