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

Sponsor

Charles University, Czech Republic (Other)

Overall Status

Completed

CT.gov ID

NCT01136187

Collaborator

University Hospital Pilsen (Other), Regional Hospital Liberec (Other), University Hospital Hradec Kralove (Other), Na Homolce Hospital (Other)

707

Enrollment

Locations

Arms

Duration (Months)

176.8

Patients Per Site

4.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Oct 1, 2009

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Oct 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

Occurrence of bleeding or entry site complications [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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country	Postal Code
1	University Hospital Hradec Kralove	Hradec Kralove	Czech Republic	50005
2	Regional Hospital Liberec	Liberec	Czech Republic	46063
3	University Hospital Pilsen	Pilsen	Czech Republic	30460
4	Na Homolce Hospital	Prague	Czech Republic	15030