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

March 11, 2016 updated by: Total Cardiovascular Solutions

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

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

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • V.S. General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients referred for diagnostic coronary angiography

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Femoral
Coronary angiography procedures performed using transfemoral access
Left radial access
Coronary angiography procedures performed using left radial access site.
Right radial Access
Coronary angiography procedures performed using Right radial access site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Air Kerma
Time Frame: 1 day
The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.
1 day

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operator radiation exposure
Time Frame: 1 day
operator radiation exposure will be measured by a personal dosimeter worn by the operator outside the lead apron on the vest pocket.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tejas M Patel, MD, DM, Chief

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

August 23, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (Estimate)

September 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MIL/IMRC/RP/TP/10/2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Exposure to Ionizing Radiation

3
Subscribe