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Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI) (STEMI-RADIAL)

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ClinicalTrials.gov Identifier: NCT01136187
Recruitment Status : Completed
First Posted : June 3, 2010
Last Update Posted : December 21, 2012
Sponsor:
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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
ST Elevation Myocardial Infarction Procedure: Access site in primary PCI Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 707 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : October 2009
Actual Primary Completion Date : April 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Occurrence of bleeding or entry site complications [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Occurence of major adverse cardiovascular events
  2. Primary access site failure - conversion to another access
  3. Angiographical procedural success
  4. Contrast media consumption
  5. Procedural and fluoroscopic times
  6. Duration of hospital / ICU stay
  7. TVR/TLR + any new hospitalization

Eligibility Criteria
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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

    1. 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.
    2. 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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 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
ST Elevation Myocardial Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases