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

Acute Coronary Syndromes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128035
• Other study ID #: RADIATION PROTECT
• Secondary ID: Project Number 1
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: April 27, 2015
• Start date: December 2013
• Est. completion date: June 2014

Study information

• Verified date: April 2015
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Intervention

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.

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Dr. Sanjit S. Jolly	McMaster University, Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Duration of Procedure (an expected average of 30 minutes)	No
Secondary	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.	Duration of Procedure (an expected average of 30 minutes)	No