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

Exposure to Ionizing Radiation Clinical Trial

— REVERE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01677481
• Other study ID #: MIL/IMRC/RP/TP/10/2010
• Status: Completed
• Phase: N/A
• First received: August 23, 2012
• Last updated: March 11, 2016
• Start date: February 2011
• Est. completion date: August 2014

Study information

• Verified date: March 2016
• Source: Total Cardiovascular Solutions
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Exposure to Ionizing Radiation

Locations

Country	Name	City	State
India	V.S. General Hospital	Ahmedabad	Gujarat

Sponsors (1)

Lead Sponsor	Collaborator
Total Cardiovascular Solutions

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Operator radiation exposure	operator radiation exposure will be measured by a personal dosimeter worn by the operator outside the lead apron on the vest pocket.	1 day	No
Primary	Air Kerma	The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.	1 day	No