Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial

Completed

• Conditions: Exposure to Ionizing Radiation

• Registration Number: NCT01677481
• Lead Sponsor: Total Cardiovascular Solutions

Brief Summary

The study compares radiation exposure parameters between coronary angiography procedures performed by left wrist, right wrist or groin (femoral) procedure access site

Detailed Description

Patients referred for coronary angiography will be randomized to either left radial, right radial or femoral arterial access sites, and the coronary angiogram will be performed in a standard fashion, including left ventriculography. Radiation exposure parameters including Air Kerma, Dose-area product, Fluoroscopy time and Operator radiation exposure will be recorded. Operator experience as well as demographic data will be recorded.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2012-08-23
• Study First Submitted QC: 2012-08-31
• Study First Posted: 2012-09-03
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• All patients undergoing diagnostic coronary angiography

Exclusion Criteria

• non-availability of one or more of the three access sites History of coronary artery bypass graft surgery Need for percutaneous coronary intervention.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Air Kerma	1 day	The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.

Trial Locations

Locations (1)

V.S. General Hospital; 🇮🇳 Ahmedabad, Gujarat, India