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NCT Number: NCT07689591

Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

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.

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Key information

Conditions

STEMI - ST Elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Leg Ulcer Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Firat University, Elâzığ, Elaziğ, Turkey (Türkiye)

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About this study

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?

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Presence of Spontaneous Coronary Reperfusion Before Primary PCI

    Time frame: 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

Secondary outcomes

  1. ST-Segment Resolution After Primary PCI

    Time frame: 90 minutes after primary PCI

    ST-segment resolution will be assessed by comparing the baseline electrocardiogram with the electrocardiogram obtained after primary percutaneous coronary intervention. ST-segment resolution will be calculated based on the change in ST-segment elevation in the lead with the highest baseline ST elevation.

  2. Left Ventricular Ejection Fraction

    Time frame: Within 48 hours after primary PCI

    Left ventricular ejection fraction will be measured by echocardiography. The post-procedural left ventricular ejection fraction value will be used for outcome assessment.

  3. Peak-to-Baseline D-Dimer Ratio Through Day 3

    Time frame: From baseline to Day 3 or hospital discharge, whichever occurs first

    The peak-to-baseline D-dimer ratio will be calculated by dividing the highest D-dimer level measured from baseline through Day 3, or until hospital discharge if discharge occurs earlier, by the baseline D-dimer level.

  4. NT-proBNP Level at Hospital Discharge

    Time frame: At hospital discharge

    NT-proBNP level will be measured at hospital discharge and compared between the study groups

  5. Contrast-Associated Acute Kidney Injury

    Time frame: From baseline to 48-72 hours after primary PCI

    Contrast-associated acute kidney injury will be defined as an increase in serum creatinine level of at least 0.3 mg/dL or at least 50% from baseline after primary percutaneous coronary intervention. Serum creatinine levels will be assessed at baseline and during hospitalization.

Study contacts

Contact information is provided by the study sponsor or research team.

ERKAN ÇEÇEN, MD

CONTACT

[email protected]

+905301178284 ext. +905301178284

MEHMET BALIN, MD,PROFFESOR

CONTACT

[email protected]

+905059174185 ext. +905301178284

Sponsors and collaborators

Lead sponsor

Firat University

Other

Registry information

Official study title

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

Acronym: RE-START

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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