Fluoroscopic Pulse Rate for Radiation Exposure

Overseen By Arsalan Hashmi, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Maimonides Medical Center

Disqualifiers: Non-right radial artery access

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Periprocedural per each individual procedure

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if reducing the number of X-ray pulses during a heart procedure can lower radiation exposure for doctors. It compares two pulse rates: an ultra-low dose fluoroscopic pulse rate of 3.75 pulses per second and a standard low dose fluoroscopic pulse rate of 7.5 pulses per second. The focus is on operators using a right radial artery approach, where the procedure is performed through an artery in the wrist. This trial is suitable for patients undergoing a coronary angiogram through the right radial artery. As an unphased study, it offers patients the opportunity to contribute to research that could enhance safety in heart procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for reducing radiation exposure?

Research has shown that using a very low rate of X-ray images, such as 3.75 images per second, significantly reduces radiation exposure for doctors during procedures. Typically, up to 15 images per second are used, so lowering this rate represents a substantial change. Studies indicate that even reducing the rate to 7.5 images per second decreases radiation without causing any issues.

This suggests that using a very low rate is safe and well-tolerated. No evidence of harmful effects exists for doctors using these lower rates, which is encouraging for those considering joining trials aimed at reducing radiation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how reducing the fluoroscopic pulse rate during coronary angiography might decrease radiation exposure for operators. Unlike the standard rate of 7.5 pulses per second, the ultra-low dose approach uses only 3.75 pulses per second, potentially cutting radiation exposure in half. This could lead to safer working conditions for healthcare professionals without sacrificing the quality of diagnostic imaging.

What evidence suggests that this trial's fluoroscopic pulse rates could be effective in reducing radiation exposure?

This trial will compare two fluoroscopic pulse rates to assess radiation exposure during heart procedures. Research has shown that using a lower rate of X-ray pulses can reduce radiation exposure for doctors. Participants in this trial will receive either a standard low dose of 7.5 frames per second (FPS) or an ultra-low dose of 3.75 FPS. Studies indicate that the standard low rate already decreases radiation compared to higher rates. Early results suggest that the ultra-low rate might reduce radiation further. This reduction is important because less radiation can lead to better long-term health for both patients and doctors. Lowering the pulse rate is a simple change that can greatly improve safety. ^{1 4 6 7 8}

Who Is on the Research Team?

Bilal A Malik, MD

Principal Investigator

Maimonides Medical Center

Are You a Good Fit for This Trial?

This trial is for cardiologists performing coronary angiograms via the right radial artery. It aims to see if using an ultra-low fluoroscopic pulse rate reduces their radiation exposure compared to a standard low pulse rate.

Inclusion Criteria

I am older than 18 years.

My sex or gender does not limit my participation.

My doctor uses the right wrist as the main site for procedures.

Exclusion Criteria

My heart catheterization was not done through the right wrist.

My heart cath was done through a different site, not the right radial artery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Randomized procedures performed with either 3.75 or 7.5 frames per second fluoroscopic pulse rate during coronary angiography

Periprocedural per each individual procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard low dose fluoroscopic pulse rate
• Ultra low dose fluoroscopic pulse rate

Trial Overview The study compares two fluoroscopic pulse rates: an ultra-low rate of 3.75 frames per second and a standard low rate of 7.5 frames per second, to measure radiation dose differences received by cardiologists during procedures.

How Is the Trial Designed?

Group I: Ultra-low dose 3.75 fluoroscopic pulses per second Experimental Treatment 1 Intervention

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 II: Standard low-dose 7.5 fluoroscopic pulses per second Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Maimonides Medical Center

Lead Sponsor

Trials

72

Recruited

15,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07221175

Operator Radiation Dose Using Ultra-Low Fluoroscopic ... This trial will determine if using an ultra-low fluoroscopic pulse rate of 3.75 frames per second will reduce both physician and patient ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2014.02.005

Effectiveness of Low Rate Fluoroscopy at Reducing ... Conclusions: Fluoroscopy at 7.5 FPS, compared with 15 FPS, is a simple and effective method in reducing operator and patient radiation dose ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/jmrs.293

Feasibility of using ultra‐low pulse rate fluoroscopy during ... This project assessed the feasibility of utilising pulse rates as low as 3 pulses per second (pps) in coronary angiograms.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1936879814005172

Effectiveness of Low Rate Fluoroscopy at Reducing ... Low rate fluoroscopy at 7.5 FPS offers a simple, cost-free, yet a very effective measure to reduce both operator and patient radiation exposure during TRA in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6275260/

Lowering fluoroscopy pulse rates to reduce radiation dose ... Lowering the fluoroscopy pulse rate is a simple, yet effective method to reduce radiation dose. Sensible, iterative changes made in this area have the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6275254/

Feasibility of using ultra‐low pulse rate fluoroscopy during ... Effectiveness of low rate fluoroscopy at reducing operator and patient radiation dose during transradial coronary angiography and interventions.

7. patlynk.com patlynk.com/trial/NCT07221175

Radiation Dose Reduction in Coronary Angiography This study focuses on finding ways to reduce radiation exposure for doctors performing coronary angiography, a procedure that looks at the heart's blood ...

8. frontiersin.org frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2021.625873/full

Radiation Exposure Reduction and Patient Outcome by ... Multiple prior studies have demonstrated that decreasing the fluoroscopy frame rate from 15 to 7.5 fps can lead to significant fall in radiation ...