Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

Официальное название

Noninvasive Artificial Venous Stasis and Coronary Reperfusion in ST-Segment Elevation Myocardial Infarction:The RE-START STEMI Randomized Trial

Обзор

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.

Подробное описание

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?

Первичные конечные точки

• Presence of Spontaneous Coronary Reperfusion Before Primary PCI [Срок оценки: Periprocedural]

Вторичные конечные точки (5)

• ST-Segment Resolution After Primary PCI [Срок оценки: 90 minutes after primary PCI]
• Left Ventricular Ejection Fraction [Срок оценки: Within 48 hours after primary PCI]
• Peak-to-Baseline D-Dimer Ratio Through Day 3 [Срок оценки: From baseline to Day 3 or hospital discharge, whichever occurs first]
• NT-proBNP Level at Hospital Discharge [Срок оценки: At hospital discharge]
• Contrast-Associated Acute Kidney Injury [Срок оценки: From baseline to 48-72 hours after primary PCI]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Turkey (Türkiye) · 2 центра

• Firat University — Elâzığ
• Firat University — Elâzığ

Идентификаторы

NCT: NCT07689591 · 2024/03-28

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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