Radiation MonitoringPhase 3NCT01510353
Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
A Phase 3 study testing Radiation monitoring device in people with Radiation Monitoring and Radiation Protection, run by North Texas Veterans Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Monitoring, Radiation Protection
- What is being tested?
- Radiation monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 505 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to May 2014
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing clinically-indicated cardiac catheterization
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
VA North Texas Health Care System
Dallas, Texas, 75216
About this study
The purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.
- Conditions
- Radiation Monitoring, Radiation Protection
- Being tested
- Radiation monitoring device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation monitoring deviceDevice
Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization
| Study group | Role | What they receive |
|---|---|---|
| Use of a radiation monitoring device | Experimental | Use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization Receives: Device: Radiation monitoring device |
| No use of radiation monitoring device | No intervention | No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation exposure of the operator
Radiation exposure of the operator (measured in mrem by the real time monitoring device)
Measured: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Secondary outcomes (1)
Radiation exposure of the patient
Radiation exposure of the patient, as measured by the X-ray machine using (a) air kerma dose, (b) dose area product, (c) fluoroscopy and cineangiography time
Measured: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation MonitoringStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 505 participants (actual)
Sponsor and investigators
- Lead sponsor
- North Texas Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Emmanouil Brilakis, North Texas Veterans Healthcare System
- Investigators
- Emmanouil S. Brilakis, MD, PhD, Study chair, North Texas Veterans Healthcare SystemSubhash Banerjee, MD, Study director, North Texas Veterans Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510353
- Sponsor's protocol ID
- 11-097
- Status last verified
- Jul 2014
- First submitted
- 9 Jan 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
Publications
Christopoulos G, Papayannis AC, Alomar M, Kotsia A, Michael TT, Rangan BV, Roesle M, Shorrock D, Makke L, Layne R, Grabarkewitz R, Haagen D, Maragkoudakis S, Mohammad A, Sarode K, Cipher DJ, Chambers CE, Banerjee S, Brilakis ES. Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study. Circ Cardiovasc Interv. 2014 Dec;7(6):744-50. doi: 10.1161/CIRCINTERVENTIONS.114.001974. Epub 2014 Nov 25.
PubMed 25423958
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Real Time Radiation Monitoring Device on Radiation Exposure During Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT01510353
- Acronym / sponsor ID
- 11-097
- Conditions
- Radiation Monitoring, Radiation Protection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 505 participants (actual)
- Lead sponsor
- North Texas Veterans Healthcare SystemUS federal agency
- Study start
- Jan 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Jan 2012 (estimated)
- 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 purpose of this study is to examine the impact of using a real time radiation exposure monitoring device on the patient and operator radiation exposure during cardiac catheterization. The hypothesis of the study is that use of a real time radiation exposure monitoring device during cardiac catheterization will decrease both patient and operator radiation exposure compared to no use of the monitoring device.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Use of a radiation monitoring device | Experimental | Device: Radiation monitoring deviceUse of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization |
| No use of radiation monitoring device | No intervention | –No use of a radiation monitoring device that provides real-time auditory feedback on radiation exposure during cardiac catheterization |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing clinically-indicated cardiac catheterization
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Radiation monitoring deviceRadiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization | Device | Use of a radiation monitoring device |
Primary outcome
Radiation exposure of the operator
Time frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Radiation exposure of the operator (measured in mrem by the real time monitoring device)
1 secondary outcome
Radiation exposure of the patient
Time frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2014.
- Derived from this study: PubMed 25423958Christopoulos G, Papayannis AC, Alomar M, Kotsia A, Michael TT, Rangan BV, Roesle M, Shorrock D, Makke L, Layne R, Grabarkewitz R, Haagen D, Maragkoudakis S, Mohammad A, Sarode K, Cipher DJ, Chambers CE, Banerjee S, Brilakis ES. Effect of a real-time radiation monitoring device on operator radiation exposure during cardiac catheterization: the radiation reduction during cardiac catheterization using real-time monitoring study. Circ Cardiovasc Interv. 2014 Dec;7(6):744-50. doi: 10.1161/CIRCINTERVENTIONS.114.001974. Epub 2014 Nov 25.
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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.
Emmanouil S. Brilakis, MD, PhD study chair
North Texas Veterans Healthcare System
Subhash Banerjee, MD study director
North Texas Veterans Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Radiation monitoring device in people with Radiation Monitoring and Radiation Protection, run by North Texas Veterans Healthcare System 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Jul 2014. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of the operator (time frame: radiation exposure will be measured for the duration of the catheterization procedure, an expected average of one hour). 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 NCT01510353, which also lists 1 linked publication.
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 4 Jul 2014.