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

Not Applicable

Completed

• Conditions: Acute Coronary Syndromes
• Interventions: Procedure: With Lead Shield

• Registration Number: NCT02128035
• Lead Sponsor: Dr. Sanjit S. Jolly

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 Timeline

• Study First Submitted: 2012-12-20
• Study Start: 2013-12
• Study First Submitted QC: 2014-04-29
• Primary Completion: 2014-05
• Study First Posted: 2014-05-01
• Study Completion: 2014-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Lead Shield	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.

Primary Outcome Measures

Name	Time	Method
Total Radiation Dose	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

Name	Time	Method
Radiation Exposure Dose per minute	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.

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada