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Radiation Dose Reduction in Coronary Angiography

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Study AimThis 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

Radiation Exposure

+ Radiation Exposure to Operator
Over 18 Years
+6 Eligibility Criteria

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, RCIS
Last updated: October 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual 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. 
Principal SponsorMaimonides Medical Center
Study ContactRichard Casazza, MAS, RT, RCIS
Last updated: October 27, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Radiation Exposure
Radiation Exposure to Operator
Criteria
4 inclusion criteria required to participate
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
2 exclusion criteria prevent from participating
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

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
Secondary Objectives

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

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 CenterBrooklyn, United StatesSee the location
Recruiting soonOne Study Center