Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

Official title

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

Overview

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.

Detailed description

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?

Primary outcome measures

• Presence of Spontaneous Coronary Reperfusion Before Primary PCI [Time frame: Periprocedural]

Secondary outcome measures (5)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-control

Study locations

Turkey (Türkiye) · 2 centers

• Firat University — Elâzığ
• Firat University — Elâzığ

Identifiers

NCT: NCT07689591 · 2024/03-28

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗