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| Name | Class |
|---|---|
| University Hospital Pilsen | OTHER |
| Regional Hospital Liberec | OTHER |
| University Hospital Hradec Kralove | OTHER |
| Na Homolce Hospital |
Percutaneous coronary interventions (PCIs) from the femoral approach have more bleeding complications related to access site in comparison to the radial approach in patients with acute coronary syndrome (ACS). Major bleeding and access site complications have an important role in results of PCI for ACS and lead to higher morbidity and mortality. Primary PCIs in ST elevation myocardial infarction (STEMI) are associated with more aggressive antithrombotic treatment than in elective or semi-urgent interventions. Currently, both radial and femoral approaches are routinely used for primary PCI in STEMI. However, only non-randomized studies and registries or small randomized single center studies comparing both approaches in primary PCI have been published until now. The aim of STEMI-RADIAL trial is to evaluate potential reduction of bleeding complications in the radial approach primary PCI compared to femoral approach in randomized, multicenter study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radial approach | Experimental | Primary percutaneous coronary intervention from the radial approach |
|
| Femoral approach | Active Comparator | Primary percutaneous coronary intervention from the femoral approach |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Access site in primary PCI | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of bleeding or entry site complications | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of major adverse cardiovascular events | ||
| Primary access site failure - conversion to another access | ||
| Angiographical procedural success |
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Inclusion Criteria:
Age over 18 years
Admission for STEMI less than 12 hours after onset of symptoms
Ability to sign written informed consent
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hradec Kralove | Hradec Králové | 50005 | Czechia | |||
| Regional Hospital Liberec |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24211309 | Derived | Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| D009203 | Myocardial Infarction |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| OTHER |
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| Contrast media consumption |
| Procedural and fluoroscopic times |
| Duration of hospital / ICU stay |
| TVR/TLR + any new hospitalization |
| Liberec |
| 46063 |
| Czechia |
| University Hospital Pilsen | Pilsen | 30460 | Czechia |
| Na Homolce Hospital | Prague | 15030 | Czechia |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |