Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors (EXPERT)

This study has been completed.
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: September 16, 2014
Last verified: September 2014
  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

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

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


Secondary Outcome Measures:
  • Physician radiation exposure (in uSv) [ Time Frame: during coronary angiography ] [ 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
Study Completion Date: March 2014
Primary Completion Date: January 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794325

Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, RS, Brazil, 90520-000
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: September 16, 2014
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
Coronary Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014