NCT01136187

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
707

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

December 21, 2012

Status Verified

December 1, 2012

Enrollment Period

2.5 years

First QC Date

June 2, 2010

Last Update Submit

December 20, 2012

Conditions

ST Elevation Myocardial Infarction

Keywords

Myocardial infarctionPrimary percutaneous coronary interventionRadialBleeding

Outcome Measures

Primary Outcomes (1)

  • Occurrence of bleeding or entry site complications

    30 days

Secondary Outcomes (7)

  • Occurence of major adverse cardiovascular events

  • Primary access site failure - conversion to another access

  • Angiographical procedural success

  • Contrast media consumption

  • Procedural and fluoroscopic times

  • +2 more secondary outcomes

Study Arms (2)

Radial approach

EXPERIMENTAL

Primary percutaneous coronary intervention from the radial approach

Procedure: Access site in primary PCI

Femoral approach

ACTIVE COMPARATOR

Primary percutaneous coronary intervention from the femoral approach

Procedure: Access site in primary PCI

Interventions

Access site in primary PCIPROCEDURE
Femoral approachRadial approach

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Hradec Kralove

Hradec Králové, 50005, Czechia

Location

Regional Hospital Liberec

Liberec, 46063, Czechia

Location

University Hospital Pilsen

Pilsen, 30460, Czechia

Location

Na Homolce Hospital

Prague, 15030, Czechia

Location

Related Publications (1)

  • 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.

    PMID: 24211309DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionMyocardial InfarctionHemorrhage

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

October 1, 2009

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

December 21, 2012

Record last verified: 2012-12

Locations

CZ(4)