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

NCT07221175 | Withdrawn DMC FDA Device

• 1 other identifier: 2024-12-08-MMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation Exposure; Radiation Exposure to Operator

Keywords

Radiation exposure; Radial approach; Cardiac catheterization; Coronary angiography

Outcome Measures

Primary Outcomes (1)

• Radiation exposure to the operator

  To observe the difference of radiation exposure (cumulative and normalized) at the level of the thorax, left eye, and right eye of the operator comparing a 7.5 fluoroscopic pulse rate and an ultra-low 3.75 fluoroscopic pulse rate

  Periprocedural per each individual procedure

Secondary Outcomes (1)

• Radiation exposure to patient

  Periprocedural per each individual procedure

Study Arms (2)

Ultra-low dose 3.75 fluoroscopic pulses per second

EXPERIMENTAL

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

Radiation: Ultra low dose fluoroscopic pulse rate

Standard low-dose 7.5 fluoroscopic pulses per second

ACTIVE COMPARATOR

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

Radiation: Standard low dose fluoroscopic pulse rate

Interventions

Standard low dose fluoroscopic pulse rate RADIATION

Standard low dose 7.5 fluoroscopic pulses per second

Standard low-dose 7.5 fluoroscopic pulses per second

Ultra low dose fluoroscopic pulse rate RADIATION

Ultra low dose 3.75 fluoroscopic pulses per second

Ultra-low dose 3.75 fluoroscopic pulses per second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Related Publications (2)

• 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.

  PMID: 25097198 RESULT

• 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.

  PMID: 24746649 RESULT

Study Officials

• Bilal A Malik, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 27, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD will be available following termination of the data collection and analysis (date to be determined, estimate 2/1/2027) for up to 3 years (2/1/2030).
• Access Criteria: IPD can be requested by e-mailing the primary contact point.

Locations

US (1)