Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

NCT07689591 | Recruiting DMC

• 1 other identifier: 2024/03-28
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Keywords

STEMI; Spontaneous Reperfusion; Primary Percutaneous Coronary Intervention; Infarct-Related Artery; TIMI Flow; Venous Stasis; Noninvasive Artificial Venous Stasis; RE-START Procedure; Coronary Reperfusion

Outcome Measures

Primary Outcomes (1)

• Presence of Spontaneous Coronary Reperfusion Before Primary PCI

  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

  Periprocedural

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include adult patients admitted to Firat University Hospital with acute ST-segment elevation myocardial infarction who are eligible for and planned to undergo primary percutaneous coronary intervention. Eligible patients will be randomized before coronary angiography to either the RE-START procedure group or the sham-control group, without delaying standard STEMI management or primary PCI.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Firat University: lead

Study Sites (2)

Firat University

Elâzığ, Elaziğ, 23000, Turkey (Türkiye)

RECRUITING

Firat University

Elâzığ, Merkez, 23000, Turkey (Türkiye)

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Araştırma katılımcılarından alınan materyal örneklerinin bir biyolojik örneği saklanmayacaktır.

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Varicose Ulcer

Condition Hierarchy (Ancestors)

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

Study Officials

• MEHMET BALIN

  Firat University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MEHMET BALIN, MD,PROFFESOR

CONTACT

+905059174185; mehmetbalina@yahoo.com

ERKAN ÇEÇEN, MD

CONTACT

+905301178284; drerkancecen@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor

Study Record Dates

• First Submitted: June 30, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-06

Locations

TU (2)