- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01136187
Trial Comparing Radial and Femoral Approach in Primary Percutaneous Coronary Intervention (PCI) (STEMI-RADIAL)
December 20, 2012 updated by: Ivo Bernat, Charles University, Czech Republic
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
707
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hradec Kralove, Czech Republic, 50005
- University Hospital Hradec Kralove
-
Liberec, Czech Republic, 46063
- Regional Hospital Liberec
-
Pilsen, Czech Republic, 30460
- University Hospital Pilsen
-
Prague, Czech Republic, 15030
- Na Homolce Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Radial approach
Primary percutaneous coronary intervention from the radial approach
|
|
Active Comparator: Femoral approach
Primary percutaneous coronary intervention from the femoral approach
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Occurrence of bleeding or entry site complications
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
June 2, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 21, 2012
Last Update Submitted That Met QC Criteria
December 20, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STEMI-RADIAL 16-9-2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on ST Elevation Myocardial Infarction
-
Stiftung Institut fuer HerzinfarktforschungGlaxoSmithKline; University Hospital Muenster; Klinikum NürnbergCompletedMyocardial Infarction | ST-Elevation Myocardial Infarction | Non-ST-Elevation Myocardial InfarctionGermany
-
Azienda ULSS 5 PolesanaUniversity of PadovaUnknownMyocardial Infarction, Acute | ST Segment Elevation Myocardial Infarction | Non-ST Elevation Myocardial Infarction (nSTEMI)Italy
-
University of LeedsUniversity College, LondonCompletedST-elevation Myocardial Infarction | Non ST-elevation Myocardial Infarction
-
University Medical Centre LjubljanaCompletedCardiac Arrest | Postresuscitation Syndrome | Myocardial Infarction (ST-Elevation Myocardial Infarction and Non-ST-Elevation Myocardial Infarction)Slovenia
-
Population Health Research InstituteCanadian Institutes of Health Research (CIHR); Boston Scientific CorporationActive, not recruitingST Elevation Myocardial Infarction | Non ST Elevation Myocardial InfarctionCanada
-
Inha University HospitalCompletedST Segment Elevation Myocardial Infarction | Non-ST Segment Elevation Myocardial InfarctionKorea, Republic of
-
RenJi HospitalCompletedST Segment Elevation Myocardial Infarction
-
Dong-A UniversityTerminatedST-Segment Elevation Myocardial InfarctionKorea, Republic of
-
Azienda Ospedaliera San Camillo ForlaniniUnknownST Segment Elevation Myocardial InfarctionItaly
-
Jinan Central HospitalUnknownST-Segment Elevation Myocardial InfarctionChina
Clinical Trials on Access site in primary PCI
-
Acibadem UniversityCompleted
-
Terumo Europe N.V.CompletedAcute ST Segment Elevation Myocardial InfarctionBrazil, Serbia, Italy, Spain, Macedonia, The Former Yugoslav Republic of
-
Rigshospitalet, DenmarkActive, not recruitingST Segment Elevation Myocardial InfarctionDenmark
-
RTI SurgicalTerminatedKnee InjuryUnited States
-
Minneapolis Heart Institute FoundationNational Heart, Lung, and Blood Institute (NHLBI)CompletedAcute Myocardial InfarctionUnited States
-
Maatschap Cardiologie ZwolleTerumo Europe N.V.CompletedComplex Coronary LesionsNetherlands, Belgium, Germany, Switzerland, United Kingdom
-
Fundacja Ośrodek Badań MedycznychCompletedMyocardial InfarctionPoland, Slovenia
-
University Hospital, CaenCompleted
-
Azienda Ospedaliero Universitaria Maggiore della...Completed
-
RTI SurgicalTerminated