- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510353
Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
July 2, 2014 updated by: Emmanouil Brilakis, North Texas Veterans Healthcare System
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
505
Phase
- Phase 3
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
-
-
Texas
-
Dallas, Texas, United States, 75216
- VA North Texas Health Care System
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing clinically-indicated cardiac catheterization
Exclusion Criteria:
- None
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Emmanouil S. Brilakis, MD, PhD, North Texas Veterans Healthcare System
- Study Director: Subhash Banerjee, MD, North Texas Veterans Healthcare System
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
January 1, 2012
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
January 9, 2012
First Submitted That Met QC Criteria
January 11, 2012
First Posted (Estimate)
January 16, 2012
Study Record Updates
Last Update Posted (Estimate)
July 4, 2014
Last Update Submitted That Met QC Criteria
July 2, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 11-097
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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