Skip to main content
OpenTrials
Completed

NCT Number: NCT02128035

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

With Lead Shield

Procedure

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 outcomes

  1. Total Radiation Dose

    Time frame: Duration of Procedure (an expected average of 30 minutes)

    • 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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Dr. Sanjit S. Jolly

Other

Collaborators

  • McMaster University
  • Population Health Research Institute

Registry information

Official study title

Radiation Protection With a Pelvic Lead Shield and a Radiation Protection Cap for Operators Performing Coronary Angiography or Intervention, a Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 1, 2014
Registry last updated
Apr 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.