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

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ClinicalTrials.gov Identifier: NCT01510353
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System

Brief Summary:
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 or disease Intervention/treatment Phase
Radiation Monitoring Radiation Protection Device: Radiation monitoring device Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
Study Start Date : January 2012
Primary Completion Date : May 2014
Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]
    Radiation exposure of the operator (measured in mrem by the real time monitoring device)


Secondary Outcome Measures :
  1. 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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing clinically-indicated cardiac catheterization

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510353


Locations
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
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