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

ST Elevation Myocardial Infarction Clinical Trial

— STEMI-RADIAL  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136187
• Other study ID #: STEMI-RADIAL 16-9-2009
• Status: Completed
• Phase: N/A
• First received: June 2, 2010
• Last updated: December 20, 2012
• Start date: October 2009
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 707
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction

Intervention

Procedure:
• Access site in primary PCI

Locations

Country	Name	City	State
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove
Czech Republic	Regional Hospital Liberec	Liberec
Czech Republic	University Hospital Pilsen	Pilsen
Czech Republic	Na Homolce Hospital	Prague

Sponsors (5)

Lead Sponsor	Collaborator
Charles University, Czech Republic	Na Homolce Hospital, Regional Hospital Liberec, University Hospital Hradec Kralove, University Hospital Pilsen

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of bleeding or entry site complications		30 days
Secondary	Occurence of major adverse cardiovascular events
Secondary	Primary access site failure - conversion to another access
Secondary	Angiographical procedural success
Secondary	Contrast media consumption
Secondary	Procedural and fluoroscopic times
Secondary	Duration of hospital / ICU stay
Secondary	TVR/TLR + any new hospitalization