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

Conditions

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

  • Canada
    • 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
Device: Novel Lead Based Armboard
Novel Lead Based Armboard
Placebo Comparator: Standard Armboard
Device: 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

London Health Sciences Centre

Collaborators

Western University, Canada

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

Keywords

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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