EXPERT: Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

Sponsor

Instituto de Cardiologia do Rio Grande do Sul (Other)

Overall Status

Completed

CT.gov ID

NCT01794325

Collaborator

Hospital Ernesto Dornelles (Other)

300

Enrollment

Location

Arms

12.9

Duration (Months)

23.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Exposure to Ionizing Radiation Coronary Heart Disease Vascular Access Complication	Other: Trans-radial Other: Trans-femoral	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Transradial and Transfemoral Approach by EXPERienced Operators in Daily rouTine (EXPERT): a Randomized, Non-inferiority Trial

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jan 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Patient radiation exposure (mGy) [during coronary angiography]
Patient radiation exposure (mGy)

Secondary Outcome Measures

Physician radiation exposure (in uSv) [during coronary angiography]
Physician radiation exposure (in uSv)

Other Outcome Measures

Major adverse cardiac events [30 days]
Major adverse cardiac events (death, stroke and vascular complications)

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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
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, Hospital Ernesto Dornelles
Principal Investigator: Claudio V Moraes, MD, Insituto de Cardiologia do Rio Grande do Sul