Radiation ExposureNCT07221175
Operator Radiation Dose Using Ultra-Low Fluoroscopic Pulse Rate Versus Standard In Performing Coronary Angiography Via Right Radial Artery
A study testing Ultra low dose fluoroscopic pulse rate and Standard low dose fluoroscopic pulse rate in people with Radiation Exposure and Radiation Exposure to Operator, run by Maimonides Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Radiation Exposure, Radiation Exposure to Operator
- What is being tested?
- Ultra low dose fluoroscopic pulse rate and Standard low dose fluoroscopic pulse rate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation 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.
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.
Read the detailed description
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.
- Conditions
- Radiation Exposure, Radiation Exposure to Operator
- Being tested
- Ultra low dose fluoroscopic pulse rate, Standard low dose fluoroscopic pulse rate
- Keywords
- Radiation exposure, Radial approach, Cardiac catheterization, Coronary angiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultra low dose fluoroscopic pulse rateRadiation
Ultra low dose 3.75 fluoroscopic pulses per second
Standard low dose fluoroscopic pulse rateRadiation
Standard low dose 7.5 fluoroscopic pulses per second
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Ultra low dose fluoroscopic pulse rate |
| 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 Receives: Radiation: Standard low dose fluoroscopic pulse rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Periprocedural per each individual procedure
Secondary outcomes (1)
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
Measured: Periprocedural per each individual procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start1 Nov 2025 (estimated)
- Primary completion31 Oct 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Why it stopped: The study team did not meet conditions dictated by the IRB committee for study approval.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maimonides Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bilal A Malik, MD, Principal investigator, Maimonides Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221175
- Sponsor's protocol ID
- 2024-12-08-MMC
- Status last verified
- Mar 2026
- First submitted
- 20 Oct 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Radiation exposure measured per dosimeter per procedure for the operators, and patient radiation exposure per procedure.
Publications
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.
PubMed 25097198Abdelaal 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.
PubMed 24746649
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation 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.
- ClinicalTrials.gov ID
- NCT07221175
- Acronym / sponsor ID
- 2024-12-08-MMC
- Conditions
- Radiation Exposure, Radiation Exposure to Operator
- Keywords
- Radiation exposure, Radial approach, Cardiac catheterization, Coronary angiography
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team did not meet conditions dictated by the IRB committee for study approval.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Maimonides Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 27 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultra-low dose 3.75 fluoroscopic pulses per second | Experimental | Radiation: Ultra low dose fluoroscopic pulse rateRadiation 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: Standard low dose fluoroscopic pulse rateRadiation 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultra low dose fluoroscopic pulse rateUltra low dose 3.75 fluoroscopic pulses per second | Radiation | Ultra-low dose 3.75 fluoroscopic pulses per second |
| Standard low dose fluoroscopic pulse rateStandard low dose 7.5 fluoroscopic pulses per second | Radiation | Standard low-dose 7.5 fluoroscopic pulses per second |
Primary outcome
Radiation exposure to the operator
Time frame: Periprocedural per each individual procedure
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
1 secondary outcome
Radiation exposure to patient
Time frame: Periprocedural per each individual procedure
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Results publication: PubMed 25097198Agarwal 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.
- Results publication: PubMed 24746649Abdelaal 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.
- Individual participant dataSharing planned: Yes. Radiation exposure measured per dosimeter per procedure for the operators, and patient radiation exposure per procedure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilal A Malik, MD principal investigator
Maimonides Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultra low dose fluoroscopic pulse rate and Standard low dose fluoroscopic pulse rate in people with Radiation Exposure and Radiation Exposure to Operator, run by Maimonides Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation exposure to the operator (time frame: Periprocedural per each individual procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.