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

Primary Purpose

Acute Coronary Syndromes

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
With Lead Shield
Sponsored by
Dr. Sanjit S. Jolly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Coronary Syndromes focused on measuring radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Without Lead Shield

With Lead Shield

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Total Radiation Dose
The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy). 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

Radiation Exposure Dose per minute
The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.

Full Information

First Posted
December 20, 2012
Last Updated
April 27, 2015
Sponsor
Dr. Sanjit S. Jolly
Collaborators
McMaster University, Population Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02128035
Brief Title
RADIATION PROTECTion With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention
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 Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Sanjit S. Jolly
Collaborators
McMaster University, Population Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndromes
Keywords
radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
230 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Without Lead Shield
Arm Type
No Intervention
Arm Description
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.
Arm Title
With Lead Shield
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
With Lead Shield
Intervention Description
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 Measure Information:
Title
Total Radiation Dose
Description
The total radiation dose that the interventional cardiologist got exposed to as read by dosimeters (µSv) at left breast. The difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (µSv/mGy). 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).
Time Frame
Duration of Procedure (an expected average of 30 minutes)
Secondary Outcome Measure Information:
Title
Radiation Exposure Dose per minute
Description
The difference between both groups in radiation exposure dose per minute (µSv /min) at left breast and left temporal region.
Time Frame
Duration of Procedure (an expected average of 30 minutes)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI) Exclusion Criteria: Age ≤ 18 years Previous inclusion in RADIATION PROTECT trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjit S Jolly, MD
Organizational Affiliation
Hamilton Health Sciences, McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ashraf Al Azzoni, MD
Organizational Affiliation
Hamilton Health Sciences Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26253734
Citation
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.
Results Reference
derived

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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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