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Radiation Dose Reduction in Coronary Angiography

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Study Aim

This study aims to investigate methods to reduce radiation exposure for patients undergoing coronary angiography.

What is being tested

Ultra low dose fluoroscopic pulse rate

+ Standard low dose fluoroscopic pulse rate

Radiation
Who is being recruted

Over 18 Years
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorMaimonides Medical Center
Study ContactRichard Casazza, MAS, RT, RCISMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on finding ways to reduce radiation exposure for doctors performing coronary angiography, a procedure that looks at the heart's blood vessels. The goal is to compare two different levels of radiation used during this procedure: a standard pulse rate and an ultra-low pulse rate. The study targets interventional cardiologists who often face radiation as a job hazard and aims to see if using a lower dose can still effectively perform the procedure while minimizing harm. This is important because reducing radiation exposure can protect both the doctors and patients involved, improving overall safety in medical settings. Participants in the study have procedures done using either the ultra-low dose or the standard dose of radiation. This is done randomly to ensure fair comparison. The procedures take place via the right radial artery, which is a common access point for these types of heart tests. Operators wear special devices called radiation dosimeters to measure the amount of radiation they receive. The study will measure both the total radiation exposure and the exposure per individual procedure. It will also look at how much radiation patients receive during these tests, giving a comprehensive view of the potential benefits of using less radiation during coronary angiography.

Official TitleEvaluation of Radiation Dose of the Operator Using an Ultra-Low Dose 3.75 Fluoroscopic Pulse Rate Versus Standard 7.5 Fluoroscopic Pulse Rate Performing Coronary Angiography Via Right Radial Artery Approach: A Randomized Clinical Trial. 
NCT07221175
Principal SponsorMaimonides Medical Center
Study ContactRichard Casazza, MAS, RT, RCISMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

338 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Maimonides Medical Center

Brooklyn, United StatesSee the location
Recruiting soonOne Study Center