Radiation Exposure Clinical Trial
— RADAROfficial title:
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board
NCT number | NCT03605030 |
Other study ID # | 108913 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 29, 2017 |
Est. completion date | May 30, 2018 |
Verified date | July 2018 |
Source | London Health Sciences Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.
Status | Completed |
Enrollment | 360 |
Est. completion date | May 30, 2018 |
Est. primary completion date | January 25, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 - Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone. Exclusion Criteria: - Inability to provide consent |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
London Health Sciences Centre | Western University, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiation dose (µSv) to the operator at the chest | Co-primary outcomes included radiation dose (µSv; mean ± SD) to the operator at the chest and forearm level. | At procedure completion | |
Primary | Radiation dose (µSv) to the operator at the forearm level | Co-primary outcomes included radiation dose (µSv; mean ± SD) to the operator at the chest and forearm level. | At procedure completion | |
Secondary | Air kerma | At procedure completion | ||
Secondary | Dose area product | At procedure completion | ||
Secondary | Radiation dose to the patient | At procedure completion |
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