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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02128035

Enrollment

230

Registered

2014-05-01

Start date

2013-12-31

Completion date

2014-06-30

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes

Keywords

radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield

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.

Interventions

PROCEDUREWith 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026