- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03605030
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures (RADAR)
July 21, 2018 updated by: Pallav Garg, London Health Sciences Centre
Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
360
Phase
- Not Applicable
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
-
-
Ontario
-
London, Ontario, Canada
- London Health Sciences Centre
-
-
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:
- Age > 18
- Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.
Exclusion Criteria:
- Inability to provide consent
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Novel Lead Based Armboard
|
Novel Lead Based Armboard
|
Placebo Comparator: Standard Armboard
|
Standard Armboard (without lead)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Radiation dose (μSv) to the operator at the chest
Time Frame: At procedure completion
|
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
|
At procedure completion
|
Radiation dose (μSv) to the operator at the forearm level
Time Frame: At procedure completion
|
Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.
|
At procedure completion
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Air kerma
Time Frame: At procedure completion
|
At procedure completion
|
Dose area product
Time Frame: At procedure completion
|
At procedure completion
|
Radiation dose to the patient
Time Frame: At procedure completion
|
At procedure completion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Pallav Garg, MBBS, MSc, London Health Sciences Centre, Western University, London, ON
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 (Actual)
May 29, 2017
Primary Completion (Actual)
January 25, 2018
Study Completion (Actual)
May 30, 2018
Study Registration Dates
First Submitted
July 21, 2018
First Submitted That Met QC Criteria
July 21, 2018
First Posted (Actual)
July 30, 2018
Study Record Updates
Last Update Posted (Actual)
July 30, 2018
Last Update Submitted That Met QC Criteria
July 21, 2018
Last Verified
July 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 108913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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