Noninvasive Artificial Venous Stasis for Reperfusion in STEMI
Recruiting
Observational Study
STEMI - ST Elevation Myocardial Infarction
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
500 (estimated)
Sponsor
Firat University · Other
Who this trial is looking for
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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.
Trial Locations
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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…
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
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