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Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors (EXPERT)

This study is currently recruiting participants.
Verified February 2013 by Instituto de Cardiologia do Rio Grande do Sul
Sponsor:
Collaborator:
CINECORS - Hospital Ernesto Dornelles
Information provided by (Responsible Party):
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT01794325
First received: February 15, 2013
Last updated: NA
Last verified: February 2013
History: No changes posted
  Purpose

Transradial approach (TRA) reduces vascular complications and access related-bleeding compared to transfemoral approach (TFA). However, this technique has been related to higher radiation exposure during coronary angiography and percutaneous coronary intervention. Previous studies have shown that TRA demands a long learning curve, and procedure success rate increases with operator's experience. Our hypothesis is that the higher radiation exposure during TRA is not a technique issue, but due to operator's expertise.

The aim of this study is to evaluate whether experienced operators with either TRA or TFA can perform diagnostic coronary angiography with similar radiation exposure.


Condition Intervention
Exposure to Ionizing Radiation
Coronary Heart Disease
Vascular Access Complication
 Other: Trans-radial
Other: Trans-femoral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • Patient radiation exposure (mGy) [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
    Patient radiation exposure (mGy)


Secondary Outcome Measures:
  • Physician radiation exposure (in uSv) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
    Physician radiation exposure (in uSv)


Other Outcome Measures:
  • Major adverse cardiac events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Major adverse cardiac events (death, stroke and vascular complications)


Estimated Enrollment: 300
Study Start Date: February 2013
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Trans-radial access
Coronary angiography performed through trans-radial access
 Other: Trans-radial
Coronary angiography performed through trans-radial access
Active Comparator: Trans-femoral access
Coronary angiography performed through trans-femoral access
 Other: Trans-femoral
Coronary angiography performed through trans-femoral access

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for a elective coronary angiography
  • Eligible for either transfemoral or transradial approach
  • Accept to sign the written consent form (WCF)

Exclusion Criteria:

  • Refusal to sign the WCF
  • End stage renal failure
  • Urgency/Emergency procedure
  • Contraindication to perform both coronary and left ventricle angiogram
  • Necessity of another vascular angiogram during coronary angiography
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01794325

Contacts
Contact: Cristiano O Cardoso, MD, MSc +55 51 3230-3626 cristiano.cardoso@cardiologia.org.br
Contact: Claudio V Moraes, MD +55 51 3230-3627 claudio_moraes@terra.com.br

Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul Recruiting
Porto Alegre, RS, Brazil, 90520-000
Contact: Julio V Teixeira, MD, MSc     +55 51 3230-3626     juliovt@terra.com.br    
Principal Investigator: Cristiano O Cardoso, MD, MSc            
Sub-Investigator: Claudio V Moraes, MD            
Sponsors and Collaborators
Instituto de Cardiologia do Rio Grande do Sul
CINECORS - Hospital Ernesto Dornelles
Investigators
Study Chair: Cristiano O Cardoso, MD, MSc Instituto de Cardiologia do Rio Grande do Sul
Study Director: Luis M Yordi, MD CINECORS - Hospital Ernesto Dornelles
Principal Investigator: Claudio V Moraes, MD Insituto de Cardiologia do Rio Grande do Sul
  More Information

No publications provided

Responsible Party: Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT01794325     History of Changes
Other Study ID Numbers: UP 4786/12
Study First Received: February 15, 2013
Last Updated: February 15, 2013
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
Occupational radiation exposure
Transradial approach
Transfemoral approach

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013