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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

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.


Condition or disease Intervention/treatment Phase
Acute Coronary Syndromes Procedure: With Lead Shield Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : June 2014

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.





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128035


Locations
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Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Dr. Sanjit S. Jolly
McMaster University
Population Health Research Institute
Investigators
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Principal Investigator: Sanjit S Jolly, MD Hamilton Health Sciences, McMaster University
Principal Investigator: Ashraf Al Azzoni, MD Hamilton Health Sciences Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Sanjit S. Jolly, Interventional Cardiologist, Associate Professor, Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02128035     History of Changes
Other Study ID Numbers: RADIATION PROTECT
Project Number 12-520 ( Other Identifier: Hamilton Health Sciences Research Ethics Board )
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015

Keywords provided by Dr. Sanjit S. Jolly, Population Health Research Institute:
radiation protection
interventional cardiologist
percutaneous coronary intervention (PCI)
angiography
lead shield

Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases