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

Dr. Sanjit S. Jolly

Status: Completed

Conditions: Acute Coronary Syndromes

Treatments: Procedure: With Lead Shield

Study type: Interventional

Funder types: Other

Identifiers

NCT02128035

RADIATION PROTECT

Project Number 12-520 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 19+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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230 participants in 2 patient groups

Without Lead Shield

No Intervention group

Description:

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.

With Lead Shield

Experimental group

Description:

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.

Treatment:

Procedure: With Lead Shield