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

NCT ID: NCT07221175

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-01
• Study Completion Date: 2027-02-01

Brief Summary

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.

Detailed 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.

Conditions

Radiation Exposure; Radiation Exposure to Operator

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Ultra-low dose 3.75 fluoroscopic pulses per second

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

Group Type: EXPERIMENTAL

Ultra low dose fluoroscopic pulse rate

Intervention Type: RADIATION

Ultra low dose 3.75 fluoroscopic pulses per second

Standard low-dose 7.5 fluoroscopic pulses per second

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

Group Type: ACTIVE_COMPARATOR

Standard low dose fluoroscopic pulse rate

Intervention Type: RADIATION

Standard low dose 7.5 fluoroscopic pulses per second

Interventions

Ultra low dose fluoroscopic pulse rate

Ultra low dose 3.75 fluoroscopic pulses per second

Intervention Type: RADIATION

Standard low dose fluoroscopic pulse rate

Standard low dose 7.5 fluoroscopic pulses per second

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maimonides Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bilal A Malik, MD

Role: PRINCIPAL_INVESTIGATOR

Maimonides Medical Center

Locations

Maimonides Medical Center

Brooklyn, New York, United States

Countries

United States

Central Contacts

Richard Casazza, MAS, RT, RCIS

Role: CONTACT

rcasazza@maimo.org

718-283-6395

Arsalan Hashmi, MBBS

Role: CONTACT

ahashmi@maimo.org

718-283-6395

Facility Contacts

Richard Casazza, MAS, RT(R)(CI)

Role: primary

rcasazza@maimo.org

718-283-6395

References

Agarwal S, Parashar A, Ellis SG, Heupler FA Jr, Lau E, Tuzcu EM, Kapadia SR. Measures to reduce radiation in a modern cardiac catheterization laboratory. Circ Cardiovasc Interv. 2014 Aug;7(4):447-55. doi: 10.1161/CIRCINTERVENTIONS.114.001499. Epub 2014 Aug 5.

Reference Type: RESULT

PMID: 25097198 (View on PubMed)

Abdelaal E, Plourde G, MacHaalany J, Arsenault J, Rimac G, Dery JP, Barbeau G, Larose E, De Larochelliere R, Nguyen CM, Allende R, Ribeiro H, Costerousse O, Mongrain R, Bertrand OF; Interventional Cardiologists at Quebec Heart-Lung Institute. Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions. JACC Cardiovasc Interv. 2014 May;7(5):567-74. doi: 10.1016/j.jcin.2014.02.005. Epub 2014 Apr 16.

Reference Type: RESULT

PMID: 24746649 (View on PubMed)

Other Identifiers

2024-12-08-MMC

Identifier Type: -

Identifier Source: org_study_id