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The study team did not meet conditions dictated by the IRB committee for study approval.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultra low dose fluoroscopic pulse rate | Radiation | Ultra low dose 3.75 fluoroscopic pulses per second |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Periprocedural per each individual procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bilal A Malik, MD | Maimonides Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides Medical Center | Brooklyn | New York | 11219 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25097198 | Result | 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. | |
| 24746649 | 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. |
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Radiation exposure measured per dosimeter per procedure for the operators, and patient radiation exposure per procedure.
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).
IPD can be requested by e-mailing the primary contact point.
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| Standard low dose fluoroscopic pulse rate | Radiation | Standard low dose 7.5 fluoroscopic pulses per second |
|