RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention

April 27, 2015 updated by: Dr. Sanjit S. Jolly

Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial

RADIATION PROTECT is a randomized, controlled trial of patients undergoing coronary angiography or PCI with or without a pelvic lead shield. Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

It is hypothesized that routine use of the pelvic lead shield and radiation protection cap during these procedures will reduce the amount of radiation in which the interventional cardiologists get exposed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients referred for coronary angiography or PCI will be randomized to undergo their procedure with or without the pelvic lead shield and the operator will wear a radiation protection cap.

Clinical efficacy will be assessed based on the total radiation dose that the interventional cardiologist got exposed to as well as a secondary outcome measuring the total radiation exposure dose per minute.

Study Type

Interventional

Enrollment (Actual)

230

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
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton Health Sciences

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI)

Exclusion Criteria:

  • Age ≤ 18 years
  • Previous inclusion in RADIATION PROTECT trial

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
No Intervention: Without Lead Shield

All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion.

The LEAD SHIELD will not be used in this group.

Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
Experimental: With Lead Shield

All routine measures to reduce radiation exposure (including lead aprons, lead collar, lead lenses, movable ceiling suspended lead shield with a long lead skirt attached to its lower margin) will be used as done routinely and will be left to the operators' discretion.

In this group, a LEAD SHIELD will be used. The Pelvic lead shield will be draped on patient from umbilicus to knees.

Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.
Procedure: With Lead Shield

A pelvic lead shield will be draped on patient from umbilicus to knees.

Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Radiation Dose
Time Frame: Duration of Procedure (an expected average of 30 minutes)
  1. The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast.
  2. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy).
  3. For the radiation protection cap, the primary outcome is the difference between total radiation dose as measured by two dosimeters (µSv) at left temporal region of the head of the interventional cardiologist (one on the outside of the radiation protection cap and the other one on the inside of the cap).
Duration of Procedure (an expected average of 30 minutes)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Exposure Dose per minute
Time Frame: Duration of Procedure (an expected average of 30 minutes)
The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.
Duration of Procedure (an expected average of 30 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr. Sanjit S. Jolly

Collaborators

McMaster University
Population Health Research Institute

Investigators

  • Principal Investigator: Sanjit S Jolly, MD, Hamilton Health Sciences, McMaster University
  • Principal Investigator: Ashraf Al Azzoni, MD, Hamilton Health Sciences Corporation

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.

General Publications

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

December 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

December 20, 2012

First Submitted That Met QC Criteria

April 29, 2014

First Posted (Estimate)

May 1, 2014

Study Record Updates

Last Update Posted (Estimate)

April 28, 2015

Last Update Submitted That Met QC Criteria

April 27, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RADIATION PROTECT
  • Project Number 12-520 (Other Identifier: Hamilton Health Sciences Research Ethics Board)

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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