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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT01136187
First received: June 2, 2010
Last updated: December 20, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
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 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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided by Charles University, Czech Republic

Additional 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
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by 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 29, 2014