Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

February 15, 2013
September 16, 2014
February 2013
January 2014   (final data collection date for primary outcome measure)
Patient radiation exposure (mGy) [ Time Frame: during coronary angiography ] [ Designated as safety issue: Yes ]
Patient radiation exposure (mGy)
Patient radiation exposure (mGy) [ Time Frame: 6 hours ] [ Designated as safety issue: Yes ]
Patient radiation exposure (mGy)
Complete list of historical versions of study NCT01794325 on ClinicalTrials.gov Archive Site
Physician radiation exposure (in uSv) [ Time Frame: during coronary angiography ] [ Designated as safety issue: No ]
Physician radiation exposure (in uSv)
Physician radiation exposure (in uSv) [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
Physician radiation exposure (in uSv)
Major adverse cardiac events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Major adverse cardiac events (death, stroke and vascular complications)
Same as current
 
Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors
Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Exposure to Ionizing Radiation
  • Coronary Heart Disease
  • Vascular Access Complication
  • Other: Trans-radial
    Coronary angiography performed through trans-radial access
  • Other: Trans-femoral
    Coronary angiography performed through trans-femoral access
  • Active Comparator: Trans-radial access
    Coronary angiography performed through trans-radial access
    Intervention: Other: Trans-radial
  • Active Comparator: Trans-femoral access
    Coronary angiography performed through trans-femoral access
    Intervention: Other: Trans-femoral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
March 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01794325
UP 4786/12
No
Instituto de Cardiologia do Rio Grande do Sul
Instituto de Cardiologia do Rio Grande do Sul
CINECORS - Hospital Ernesto Dornelles
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
Instituto de Cardiologia do Rio Grande do Sul
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP