Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

This study is currently recruiting participants.
Verified December 2013 by North Texas Veterans Healthcare System
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01510353
First received: January 9, 2012
Last updated: December 31, 2013
Last verified: December 2013
  Purpose

The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.


Condition Intervention Phase
Radiation Monitoring
Radiation Protection
Device: Radiation monitoring device
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • Radiation exposure of the operator [ Time Frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour ] [ Designated as safety issue: Yes ]
    Radiation exposure of the operator (measured in mrem by the real time monitoring device)


Secondary Outcome Measures:
  • Radiation exposure of the patient [ Time Frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour ] [ Designated as safety issue: Yes ]
    Radiation exposure of the patient, as measured by the X-ray machine using (a) air kerma dose, (b) dose area product, (c) fluoroscopy and cineangiography time


Estimated Enrollment: 505
Study Start Date: January 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Use of a radiation monitoring device
Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization
Device: Radiation monitoring device
Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization
No Intervention: No use of radiation monitoring device
No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510353

Contacts
Contact: Aristotelis C. Papayannis, M.D. 214-857-1581 Aristotelis.Papayannis@va.gov
Contact: Bavana V. Rangan, B.D.S. 214-857-1562 BavanaV.Rangan@va.gov

Locations
United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Contact: Aristotelis C. Papayannis, M.D.    214-857-1562    Aristotelis.Papayannis@va.gov   
Contact: Bavana V. Rangan, B.D.S.    214-857-1562    BavanaV.Rangan@va.gov   
Principal Investigator: Emmanouil S. Brilakis, M.D., Ph.D         
Sub-Investigator: Subhash Banerjee, M.D.         
Sponsors and Collaborators
North Texas Veterans Healthcare System
Investigators
Study Chair: Emmanouil S. Brilakis, MD, PhD North Texas Veterans Healthcare System
Study Director: Subhash Banerjee, MD North Texas Veterans Healthcare System
  More Information

No publications provided

Responsible Party: Emmanouil Brilakis, Director, Cardiac Catheterization Laboratories, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier: NCT01510353     History of Changes
Other Study ID Numbers: 11-097
Study First Received: January 9, 2012
Last Updated: December 31, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 17, 2014