Noninvasive Venous Stasis to Help Reperfuse the Heart in STEMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates whether a short, controlled venous return restriction using a blood pressure cuff can promote spontaneous reperfusion in the infarct-related artery before primary PCI. The approach is based on the idea that temporary venous stasis may boost natural clot-busting processes and improve TIMI flow (2 or 3) prior to intervention. Participants are adults with STEMI presenting within 12 hours who are slated for primary PCI and meet stability criteria. The study compares real RE-START procedure performance to a sham/control to see if it increases spontaneous reperfusion without delaying standard care. Outcomes focus on the rate of pre-PCI spontaneous reperfusion and related safety signals.

Why it matters

Who can join: the full rules

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

Where it's running

• Firat University
  Elâzığ, Elaziğ, Turkey (Türkiye) Recruiting
• Firat University
  Elâzığ, Merkez, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Mehmet Balin — Firat University
• Study coordinator: Mehmet Balin, Md,proffesor
• Email: mehmetbalina@yahoo.com
• Phone: +905059174185

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.