Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
This study is currently recruiting participants.
Verified May 2013 by North Texas Veterans Healthcare System
Sponsor:
North Texas Veterans Healthcare System
Information provided by (Responsible Party):
Emmanouil Brilakis, North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT01510353
First received: January 9, 2012
Last updated: May 2, 2013
Last verified: May 2013
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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: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (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: | May 2, 2013 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on June 18, 2013