Stable AnginaNCT01990924
Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention
A study testing 15 FPS and 7.5 FPS in people with Stable Angina and Unstable Angina, run by Laval University at 1 site in Canada.
Trial summary
Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Angina, Unstable Angina, Acute Coronary Syndrome
- What is being tested?
- 15 FPS and 7.5 FPS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Aug 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.
Who cannot join
- 1) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions
Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach.
Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.
Read the detailed description
Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.
- Conditions
- Stable Angina, Unstable Angina, Acute Coronary Syndrome
- Being tested
- 15 FPS, 7.5 FPS
- Keywords
- fluoroscopy, radiation, transradial, diagnostic, angiography, cardiac, coronary, angioplasty
- Medical subject headings
- Angina, Stable, Angina, Unstable, Acute Coronary Syndrome, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15 FPSRadiation
Also called Standard practice, conventional 15 frames per second (FPS)
X-ray pictures
7.5 FPSRadiation
Also called Low rate fluoroscopy at 7.5 FPS
X-ray pictures
| Study group | Role | What they receive |
|---|---|---|
| 7.5 FPS | Experimental | Low rate fluoroscopy at 7.5 frames per second (FPS) Receives: Radiation: 7.5 FPS |
| 15 FPS | Active comparator | Conventional rate fluoroscopy at 15 FPS Receives: Radiation: 15 FPS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Exposure
Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)
Measured: During Cardiac Catheterization
Radiation Exposure
Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)
Measured: During Cardiac Catheterization
Radiation Exposure
Fluoroscopy time
Measured: During Cardiac Catheterization
Secondary outcomes (2)
Procedural Characteristics
Procedural duration
Measured: During Cardiac Catheterization
Procedural Characteristics
Total contrast volume used
Measured: During Cardiac Catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
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 Stable AnginaStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olivier F. Bertrand, Laval University
- Investigators
- Olivier F Bertrand, MD PhD, Study chair, International Chair on Interventional Cardiology and Transradial Approach
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990924
- Sponsor's protocol ID
- 7.5 vs 15 Cine
- Other IDs
- 7.5 vs 15
- Status last verified
- Nov 2013
- First submitted
- 7 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Abdelaal 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 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions
- ClinicalTrials.gov ID
- NCT01990924
- Acronym / sponsor ID
- 7.5 vs 15 Cine
- Conditions
- Stable Angina, Unstable Angina, Acute Coronary Syndrome
- Keywords
- fluoroscopy, radiation, transradial, diagnostic, angiography, cardiac, coronary, angioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Nov 2013 (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.
Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach.
Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.
Detailed description
Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 7.5 FPS | Experimental | Radiation: 7.5 FPSLow rate fluoroscopy at 7.5 frames per second (FPS) |
| 15 FPS | Active comparator | Radiation: 15 FPSConventional rate fluoroscopy at 15 FPS |
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 elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.
Key exclusion criteria (1 listed)
- 1) non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.
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 |
|---|---|---|
| 15 FPSAlso: Standard practice, conventional 15 frames per second (FPS)X-ray pictures | Radiation | 15 FPS |
| 7.5 FPSAlso: Low rate fluoroscopy at 7.5 FPSX-ray pictures | Radiation | 7.5 FPS |
Primary outcome
Radiation Exposure
Time frame: During Cardiac Catheterization
Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)
Radiation Exposure
Time frame: During Cardiac Catheterization
Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)
Radiation Exposure
Time frame: During Cardiac Catheterization
Fluoroscopy time
2 secondary outcomes
Procedural Characteristics
Time frame: During Cardiac Catheterization
Procedural Characteristics
Time frame: During Cardiac Catheterization
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 25 Nov 2013.
- Derived from this study: 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.
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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.
Olivier F Bertrand, MD PhD study chair
International Chair on Interventional Cardiology and Transradial Approach
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 15 FPS and 7.5 FPS in people with Stable Angina and Unstable Angina, run by Laval University at 1 site in Canada.
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 25 Nov 2013. 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 Canada. 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 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 (time frame: During Cardiac Catheterization). The study lists 3 primary outcomes in all. 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 NCT01990924, 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 25 Nov 2013.