Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Total Cardiovascular Solutions
ClinicalTrials.gov Identifier:
NCT01677481
First received: August 23, 2012
Last updated: August 31, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition
Exposure to Ionizing Radiation

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Randomized Evaluation of Vascular Entry Site and Radiation Exposure: REVERE Trial.

Further study details as provided by Total Cardiovascular Solutions:

Primary Outcome Measures:
  • Air Kerma [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    The investigators will measure Air Kerma (cumulative) at the end of the procedure of coronary angiography.


Other Outcome Measures:
  • Operator radiation exposure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    operator radiation exposure will be measured by a personal dosimeter worn by the operator outside the lead apron on the vest pocket.


Enrollment: 1500
Study Start Date: February 2011
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients referred for diagnostic coronary angiography

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677481

Locations
India
V.S. General Hospital
Ahmedabad, Gujarat, India, 380006
Sponsors and Collaborators
Total Cardiovascular Solutions
Investigators
Principal Investigator: Tejas M Patel, MD, DM Chief
  More Information

No publications provided

Responsible Party: Total Cardiovascular Solutions
ClinicalTrials.gov Identifier: NCT01677481     History of Changes
Other Study ID Numbers: MIL/IMRC/RP/TP/10/2010
Study First Received: August 23, 2012
Last Updated: August 31, 2012
Health Authority: India: Indian Council of Medical Research

ClinicalTrials.gov processed this record on May 16, 2013