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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Presence of Spontaneous Coronary Reperfusion Before Primary PCI