Operator Radiation Dose Using Ultra-Low Fluoroscopic Pulse Rate Versus Standard In Performing Coronary Angiography Via Right Radial Artery

Maimonides Medical Center

Status: Not yet enrolling

Conditions: Radiation Exposure to Operator; Radiation Exposure

Treatments: Radiation: Standard low dose fluoroscopic pulse rate; Radiation: Ultra low dose fluoroscopic pulse rate

Study type: Interventional

Funder types: Other

Identifiers

NCT07221175

2024-12-08-MMC

Details and patient eligibility

About

The goal of this randomized clinical trial is to determine if there can be reduction in the radiation exposure to the cardiologist performing a coronary angiogram via a right radial artery approach by using a lower fluoroscopic pulse rate. Researchers will compare the radiation dose received by the primary operator using an ultra-low fluoroscopic pulse rate of 3.75 frames per second compared to the standard low pulse rate of 7.5 frames per second. Participating operators will wear multiple dosimeters, and the difference of radiation exposure will be measured.

Full description

Radiation exposure is one of the most adverse occupational hazards faced by interventional cardiologists. Though there have been many technologic advances over the years which have reduced the amount of radiation received by the operating physician, there is still a non-negligible amount of radiation that the operator is exposed to. The reduction of fluoroscopic pulse rate during cardiac catheterization has been shown to reduce both operator and patient radiation exposure. Current standard of practice is still to use up to 15 frames per second of fluoroscopy during coronary angiogram, with some centers adapting a low-dose 7.5 frames per second as standard. However, an ultra-low dose of 3.75 frames per second is not often utilized.

The right radial artery is the preferred access route for interventional cardiologists; they are familiar with working from the right side of the catheterization table and this is how standard laboratory equipment has historically been configured. This trial will determine if using an ultra-low fluoroscopic pulse rate of 3.75 frames per second will reduce both physician and patient radiation exposure, compared to the low-dose pulse rate of 7.5 frames per second being utilized in coronary angiography performed via right radial approach.

Procedures will be randomized to be performed with either the 3.75 frames per second or 7.5 frames per second. Only diagnostic procedures performed via right radial approach will be included. The primary operators will be equipped with radiation dosimeters at the level of the thorax and the right and left eyes. Both cumulative and normalized levels of radiation will be assessed per individual procedure performed via right radial approach. As a secondary outcome, the difference in the radiation exposure (dose-area product and milligray) of the patient will also be measured.

Enrollment: 338 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Operators using the right radial approach as a primary access site
• Patients of any sex and gender.
• Patients Age > 18 years old.
• Patients undergoing diagnostic coronary angiogram from in-patient and out-patient settings from the right radial artery approach

Exclusion criteria

• All operators performing cardiac catheterization from an access point other than the right radial artery
• All patients undergoing cardiac catheterization from an access point other than the right radial artery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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338 participants in 2 patient groups

Ultra-low dose 3.75 fluoroscopic pulses per second

Experimental group

Description:

Radiation exposure to the operator performing diagnostic coronary angiography via right radial artery approach utilizing an ultra-low dose fluoroscopic pulse rate of 3.75 frames per second

Treatment:

Radiation: Ultra low dose fluoroscopic pulse rate

Standard low-dose 7.5 fluoroscopic pulses per second

Active Comparator group

Description:

Radiation exposure to the operator performing diagnostic coronary angiography via right radial artery approach utilizing a standard low dose fluoroscopic pulse rate of 7.5 frames per second

Treatment:

Radiation: Standard low dose fluoroscopic pulse rate