Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Total Cardiovascular Solutions
ClinicalTrials.gov Identifier:
NCT01677481
First received: August 23, 2012
Last updated: March 11, 2016
Last verified: March 2016
  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.

Resource links provided by NLM:


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
Study Completion Date: August 2014
Primary Completion Date: August 2014 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: March 11, 2016
Health Authority: India: Indian Council of Medical Research
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 27, 2016