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STEMI - ST Elevation Myocardial InfarctionRE-STARTNCT07689591

Noninvasive Artificial Venous Stasis for Reperfusion in STEMI

An observational study of STEMI - ST Elevation Myocardial Infarction, run by Firat University at 2 sites in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
How many people
500 participants
Where
2 sitesTurkey (Türkiye)
Study dates
15 Aug 2026to 1 Jan 2027
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

MEHMET BALIN, MD,PROFFESOR contact

+905059174185 ext. +905301178284

mehmetbalina@yahoo.com

ERKAN ÇEÇEN, MD contact

+905301178284 ext. +905301178284

drerkancecen@gmail.com

Turkey (Türkiye)2 sites, 2 recruiting

  • Firat University

    Elâzığ, Elaziğ, 23000

    MEHMET ALI KOBAT, MD,PROFESSOR, +905322962880 ext. +905322962880, mkobat@firat.edu.tr

    Recruiting

  • Firat University

    Elâzığ, Merkez, 23000

    MEHMET ALI KOBAT, MD,PROFESSOR, +905322962880, mkobat@firat.edu.tr

    ERKAN ÇEÇEN, MD

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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?

Keywords
STEMI, Spontaneous Reperfusion, Primary Percutaneous Coronary Intervention, Infarct-Related Artery, TIMI Flow, Venous Stasis, Noninvasive Artificial Venous Stasis, RE-START Procedure, Coronary Reperfusion
Medical subject headings
ST Elevation Myocardial Infarction, Varicose Ulcer

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Periprocedural

Secondary outcomes (5)

  1. ST-Segment Resolution 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.

    Measured: 90 minutes after primary PCI

  2. Left Ventricular Ejection Fraction

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

    Measured: Within 48 hours after primary PCI

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

    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.

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

  4. NT-proBNP Level at Hospital Discharge

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

    Measured: At hospital discharge

  5. Contrast-Associated Acute Kidney Injury

    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.

    Measured: From baseline to 48-72 hours after primary PCI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start15 Aug 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07689591
Sponsor's protocol ID
2024/03-28
Acronym
RE-START
Status last verified
Aug 2026
First submitted
30 Jun 2026
Last updated
18 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of STEMI - ST Elevation Myocardial Infarction, run by Firat University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact MEHMET BALIN, MD,PROFFESOR (+905059174185 ext. +905301178284, mehmetbalina@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of Spontaneous Coronary Reperfusion Before Primary PCI (time frame: Periprocedural). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07689591.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.

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