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Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI) (STEMI-RADIAL)
This study has been completed.
Sponsor:
Charles University, Czech Republic
Collaborators:
University Hospital Pilsen
Regional Hospital Liberec
University Hospital Hradec Kralove
Na Homolce Hospital
Information provided by (Responsible Party):
Ivo Bernat, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01136187
First received: June 2, 2010
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
| ST Elevation Myocardial Infarction | Procedure: Access site in primary PCI |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ST Elevation Myocardial Infarction Treated by RADIAL or Femoral Approach - Randomized Multicenter Study Comparing Radial Versus Femoral Approach in Primary PCI. The STEMI-RADIAL Trial. |
Resource links provided by NLM:
Further study details as provided by Ivo Bernat, Charles University, Czech Republic:
Primary Outcome Measures:
- Occurrence of bleeding or entry site complications [ Time Frame: 30 days ]
Secondary Outcome Measures:
- Occurence of major adverse cardiovascular events
- Primary access site failure - conversion to another access
- Angiographical procedural success
- Contrast media consumption
- Procedural and fluoroscopic times
- Duration of hospital / ICU stay
- TVR/TLR + any new hospitalization
| Enrollment: | 707 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Radial approach
Primary percutaneous coronary intervention from the radial approach
|
Procedure: Access site in primary PCI |
|
Active Comparator: Femoral approach
Primary percutaneous coronary intervention from the femoral approach
|
Procedure: Access site in primary PCI |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age over 18 years
-
Admission for STEMI less than 12 hours after onset of symptoms
- Patients have typical chest pain for at least 20 minutes and have ECG changes typical for STEMI (ST elevation ≥ 2 mm in two continuous precordial leads or ST elevations ≥ 1 mm in two limb leads or new left bundle branch block) or ECG changes compatible with true posterior MI.
- Patients are planned to be treated with primary PCI
- Ability to sign written informed consent
Exclusion Criteria:
- Killip IV class or unconsciousness
- Patient disagreement
- Prior aortobifemoral bypass
- Absence of both radial or femoral artery pulsation
- Participation in another clinical trial randomizing ACS patients using antithrombotic drug.
- Negative Allen's test or Barbeau test type D
- Treatment with oral anticoagulants
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01136187
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136187
Locations
| Czech Republic | |
| University Hospital Hradec Kralove | |
| Hradec Kralove, Czech Republic, 50005 | |
| Regional Hospital Liberec | |
| Liberec, Czech Republic, 46063 | |
| University Hospital Pilsen | |
| Pilsen, Czech Republic, 30460 | |
| Na Homolce Hospital | |
| Prague, Czech Republic, 15030 | |
Sponsors and Collaborators
Charles University, Czech Republic
University Hospital Pilsen
Regional Hospital Liberec
University Hospital Hradec Kralove
Na Homolce Hospital
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ivo Bernat, MD, PhD, Charles University, Czech Republic |
| ClinicalTrials.gov Identifier: | NCT01136187 History of Changes |
| Other Study ID Numbers: |
STEMI-RADIAL 16-9-2009 |
| Study First Received: | June 2, 2010 |
| Last Updated: | December 20, 2012 |
Keywords provided by Ivo Bernat, Charles University, Czech Republic:
|
Myocardial infarction Primary percutaneous coronary intervention Radial Bleeding |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on July 21, 2017