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

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ClinicalTrials.gov Identifier: NCT02128035
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : April 28, 2015
Sponsor:
Collaborators:
McMaster University
Population Health Research Institute
Information provided by (Responsible Party):
Dr. Sanjit S. Jolly, Population Health Research Institute

Tracking Information
First Submitted Date  ICMJE December 20, 2012
First Posted Date  ICMJE May 1, 2014
Last Update Posted Date April 28, 2015
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
Official Title  ICMJE Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
Brief Summary

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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Acute Coronary Syndromes
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.

    Intervention: Procedure: With Lead Shield
Publications * Alazzoni A, Gordon CL, Syed J, Natarajan MK, Rokoss M, Schwalm JD, Mehta SR, Sheth T, Valettas N, Velianou J, Pandie S, Al Khdair D, Tsang M, Meeks B, Colbran K, Waller E, Fu Lee S, Marsden T, Jolly SS. Randomized Controlled Trial of Radiation Protection With a Patient Lead Shield and a Novel, Nonlead Surgical Cap for Operators Performing Coronary Angiography or Intervention. Circ Cardiovasc Interv. 2015 Aug;8(8):e002384. doi: 10.1161/CIRCINTERVENTIONS.115.002384.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 27, 2015)
230
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2014)
226
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Age ≤ 18 years
  • Previous inclusion in RADIATION PROTECT trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02128035
Other Study ID Numbers  ICMJE RADIATION PROTECT
Project Number 12-520 ( Other Identifier: Hamilton Health Sciences Research Ethics Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Sanjit S. Jolly, Population Health Research Institute
Study Sponsor  ICMJE Dr. Sanjit S. Jolly
Collaborators  ICMJE
  • McMaster University
  • Population Health Research Institute
Investigators  ICMJE
Principal Investigator: Sanjit S Jolly, MD Hamilton Health Sciences, McMaster University
Principal Investigator: Ashraf Al Azzoni, MD Hamilton Health Sciences Corporation
PRS Account Population Health Research Institute
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP