An interventional study of Ultra low dose fluoroscopic pulse rate and Standard low dose fluoroscopic pulse rate in Radiation Exposure and Radiation Exposure to Operator, sponsored by Maimonides Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Maimonides Medical Center · Not applicable, Interventional, and Prevention
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.
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.
Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
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Exclusion Criteria:
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
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
Ultra low dose 3.75 fluoroscopic pulses per second
Standard low dose 7.5 fluoroscopic pulses per second
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
Time frame: Periprocedural per each individual procedure
Radiation exposure to patient
To observe the difference of radiation exposure to the patient (dose area product, milligray) comparing a 7.5 fluoroscopic pulse rate and an ultra-low 3.75 fluoroscopic pulse rate
Time frame: Periprocedural per each individual procedure
Plan to share: Yes — Radiation exposure measured per dosimeter per procedure for the operators, and patient radiation exposure per procedure.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
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.
This study is withdrawn, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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