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

Primary Purpose

ST Elevation Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Access site in primary PCI
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST Elevation Myocardial Infarction focused on measuring Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Hradec Kralove
  • Regional Hospital Liberec
  • University Hospital Pilsen
  • Na Homolce Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Radial approach

Femoral approach

Arm Description

Primary percutaneous coronary intervention from the radial approach

Primary percutaneous coronary intervention from the femoral approach

Outcomes

Primary Outcome Measures

Occurrence of bleeding or entry site complications

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

Full Information

First Posted
June 2, 2010
Last Updated
December 20, 2012
Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Pilsen, Regional Hospital Liberec, University Hospital Hradec Kralove, Na Homolce Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01136187
Brief Title
Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic
Collaborators
University Hospital Pilsen, Regional Hospital Liberec, University Hospital Hradec Kralove, Na Homolce Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST Elevation Myocardial Infarction
Keywords
Myocardial infarction, Primary percutaneous coronary intervention, Radial, Bleeding

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
707 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Radial approach
Arm Type
Experimental
Arm Description
Primary percutaneous coronary intervention from the radial approach
Arm Title
Femoral approach
Arm Type
Active Comparator
Arm Description
Primary percutaneous coronary intervention from the femoral approach
Intervention Type
Procedure
Intervention Name(s)
Access site in primary PCI
Primary Outcome Measure Information:
Title
Occurrence of bleeding or entry site complications
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Occurence of major adverse cardiovascular events
Title
Primary access site failure - conversion to another access
Title
Angiographical procedural success
Title
Contrast media consumption
Title
Procedural and fluoroscopic times
Title
Duration of hospital / ICU stay
Title
TVR/TLR + any new hospitalization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University Hospital Hradec Kralove
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Regional Hospital Liberec
City
Liberec
ZIP/Postal Code
46063
Country
Czech Republic
Facility Name
University Hospital Pilsen
City
Pilsen
ZIP/Postal Code
30460
Country
Czech Republic
Facility Name
Na Homolce Hospital
City
Prague
ZIP/Postal Code
15030
Country
Czech Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
24211309
Citation
Bernat I, Horak D, Stasek J, Mates M, Pesek J, Ostadal P, Hrabos V, Dusek J, Koza J, Sembera Z, Brtko M, Aschermann O, Smid M, Polansky P, Al Mawiri A, Vojacek J, Bis J, Costerousse O, Bertrand OF, Rokyta R. ST-segment elevation myocardial infarction treated by radial or femoral approach in a multicenter randomized clinical trial: the STEMI-RADIAL trial. J Am Coll Cardiol. 2014 Mar 18;63(10):964-72. doi: 10.1016/j.jacc.2013.08.1651. Epub 2013 Nov 21.
Results Reference
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Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI)

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