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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Coronary Syndromes

Intervention / Treatment
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* Procedure: With Lead Shield


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient referred for coronary angiography or Percutaneous Coronary Intervention (PCI) Exclusion Criteria: Age ≤ 18 years Previous inclusion in RADIATION PROTECT trial

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Without Lead Shield<br>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. | |
| Experimental: With Lead Shield<br>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. | Procedure: With Lead Shield<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation protection, interventional cardiologist, percutaneous coronary intervention (PCI), angiography, lead shield