Transradial and Transfemoral Coronary Angiography by EXPERienced operaTors

Coronary Heart Disease Clinical Trial

— EXPERT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01794325
• Other study ID #: UP 4786/12
• Status: Completed
• Phase: N/A
• First received: February 15, 2013
• Last updated: September 16, 2014
• Start date: February 2013
• Est. completion date: March 2014

Study information

• Verified date: September 2014
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Exposure to Ionizing Radiation
• Myocardial Ischemia
• Vascular Access Complication

Intervention

Other:
• Trans-radial
Coronary angiography performed through trans-radial access
• Trans-femoral
Coronary angiography performed through trans-femoral access

Locations

Country	Name	City	State
Brazil	Instituto de Cardiologia do Rio Grande do Sul	Porto Alegre	RS

Sponsors (2)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Hospital Ernesto Dornelles

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Major adverse cardiac events	Major adverse cardiac events (death, stroke and vascular complications)	30 days	Yes
Primary	Patient radiation exposure (mGy)	Patient radiation exposure (mGy)	during coronary angiography	Yes
Secondary	Physician radiation exposure (in uSv)	Physician radiation exposure (in uSv)	during coronary angiography	No