- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01677481
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
Conditions
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.
Sponsor
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.
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