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Research

Photo for RADIATION PROTECTION trial

RADIATION PROTECTION trial

Official Title

RADIATION PROTECTion with a pelvic lead shield for operators performing coronary angiography or intervention.

Status

Completed

Overview

To assess the utility of using a novel radiation protection lead shield in reducing radiation exposure that interventional cardiologists receive during Coronary Angiography or Percutaneous Coronary Intervention (PCI) procedures.

Study Design

Randomized, controlled trial. Patients who will undergo a coronary angiography or PCI procedure will be allocated to one of the following groups: the procedure as done routinely with or without the lead shield use (current standard practice). Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures.

Primary Endpoint

Lead Shield Comparison:
i. difference between both groups in total radiation dose (?Sv) that the interventional cardiologist got exposed to as read by the dosimeters at left breast, and
ii. difference between both groups in radiation dose that the interventional cardiologist got exposed to divided by Air Kerma (?Sv/mGy).

Number of Patients

226

Number of Sites

1

Number of Countries

1

Study Period

2013–2014

Principal Investigator

Sanjit Jolly, Ashraf Al Azzoni

Program Manager

Brandi Meeks