Stable AnginaNCT02574949
Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose
A study testing Radiation: 15 FPS Cine 15 PPS, Radiation: 7.5 low Frame rate and Low Cine in people with Stable Angina and Unstable Angina, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. 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?
- Radiation: 15 FPS Cine 15 PPS, Radiation: 7.5 low Frame rate and Low Cine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jul 2016
- 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 or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.
Who cannot join
- Patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures).
- Patients participating in other research study requiring higher cine angiography.
- ST-elevation Myocardial Infarction
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network - Peter Munk Cardiac Centre
Toronto, Ontario
About this study
Official title: Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Radiation Dose and Impact on Image Quality During Cardiac Catheterization
The investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. In addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.
Read the detailed description
Minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. Patients undergoing diagnostic angiography +/- ad hoc PCI or planned PCI, will be randomised to conventional settings (15 FPS and 15 PPS) or low frame rate settings (7.5 FPS and 15 PPS) or low Cine settings (7.5 FPS and 10 PPS). The patient radiation dose, patient radiation dose area product (DAP), and fluoroscopy time will be measured.
Statistical Analysis:
Demographic and procedural variables will be presented as percentage (categorical variable) or mean ± SD (continuous variable). Patients will be randomized into three arms - a control arm and two intervention arms. The angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. The intervention arm will consist of two groups. Group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second.
Sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. At 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. Allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.
- Conditions
- Stable Angina, Unstable Angina, Acute Coronary Syndrome
- Being tested
- Radiation: 15 FPS Cine 15 PPS, Radiation: 7.5 low Frame rate, Low Cine
- Keywords
- radiation, fluoroscopy, diagnostic
- 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.
Radiation: 15 FPS Cine 15 PPSRadiation
Also called Conventional
Radiation 15 FPS Cine 15 PPS
Radiation: 7.5 low Frame rateRadiation
Also called Low rate fluoroscopy
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Low CineRadiation
Also called Low pulse rate Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
| Study group | Role | What they receive |
|---|---|---|
| Conventional rate fluoroscopy | Active comparator | Radiation: 15 FPS Cine 15 PPS Receives: Radiation: Radiation: 15 FPS Cine 15 PPS |
| Intermediate frame rate 7.5 fps | Experimental | Radiation: 7.5 low Frame rate Receives: Radiation: Radiation: 7.5 low Frame rate |
| Low frame rate | Experimental | Low Cine 10 PPS Receives: Radiation: Low Cine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Exposure to patient
Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.
Measured: During Cardiac catheterization procedure
Secondary outcomes (1)
Image quality assessment of the coronary angiogram
Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable AnginaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimír Džavík, University Health Network, Toronto
- Investigators
- Vladimir Dzavik, MD, FRCPC, Principal investigator, UHN, Toronto, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574949
- Sponsor's protocol ID
- 15-8832-AE
- Status last verified
- Oct 2015
- First submitted
- 26 May 2015
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Radiation Dose and Impact on Image Quality During Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT02574949
- Acronym / sponsor ID
- 15-8832-AE
- Conditions
- Stable Angina, Unstable Angina, Acute Coronary Syndrome
- Keywords
- radiation, fluoroscopy, diagnostic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 14 Oct 2015 (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 investigators sought to investigate the efficacy of low frame rate (fluoroscopy at 7.5 frames per second (FPS) and Cine at 10 pulse per second (PPS) vs. conventional (15 FPS and 15 PPS) on radiation dose to the patient and the operator during coronary angiography and intervention. In addition, investigators sought to qualitatively assess the effect, if any, of the low frame rate on angiographic image quality.
Detailed description
Minimizing radiation exposure to patient and the operator is considered one of the primary safety concerns in the catheterization laboratory. Patients undergoing diagnostic angiography +/- ad hoc PCI or planned PCI, will be randomised to conventional settings (15 FPS and 15 PPS) or low frame rate settings (7.5 FPS and 15 PPS) or low Cine settings (7.5 FPS and 10 PPS). The patient radiation dose, patient radiation dose area product (DAP), and fluoroscopy time will be measured.
Statistical Analysis:
Demographic and procedural variables will be presented as percentage (categorical variable) or mean ± SD (continuous variable). Patients will be randomized into three arms - a control arm and two intervention arms. The angiographic radiation protocol will adhere to standard practice in both fluoroscopy and cine images at 15 frames/second. The intervention arm will consist of two groups. Group 1 with fluoroscopy images set at 7.5 frames/second and cine images set at 15 frames/second and group 2 with fluoroscopy set at 7.5 frames/second and cine set at 10 frames/second.
Sample size calculations are based on assuming a reduction in radiation dose in group 1 of 10% and in group 2 of 20%. At 5% significance and 80% power, a sample size of 200 patients will be required in each intervention arm. Allowing for a 10% attrition rate, a sample size of 220 patients will be required in each intervention arm with 100 patients in the control arm.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional rate fluoroscopy | Active comparator | Radiation: Radiation: 15 FPS Cine 15 PPSRadiation: 15 FPS Cine 15 PPS |
| Intermediate frame rate 7.5 fps | Experimental | Radiation: Radiation: 7.5 low Frame rateRadiation: 7.5 low Frame rate |
| Low frame rate | Experimental | Radiation: Low CineLow Cine 10 PPS |
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 or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.
Key exclusion criteria (3 listed)
- Patients who undergo procedures other than diagnostic coronary angiography or intervention (e.g. electrophysiological procedures).
- Patients participating in other research study requiring higher cine angiography.
- ST-elevation Myocardial Infarction
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: 15 FPS Cine 15 PPSAlso: ConventionalRadiation 15 FPS Cine 15 PPS | Radiation | Conventional rate fluoroscopy |
| Radiation: 7.5 low Frame rateAlso: Low rate fluoroscopyRadiation: Frame rate 7.5 FPS, Cine 15 PPS | Radiation | Intermediate frame rate 7.5 fps |
| Low CineAlso: Low pulse rate CineRadiation: Frame rate 7.5 FPS, Cine 10 PPS | Radiation | Low frame rate |
Primary outcome
Radiation Exposure to patient
Time frame: During Cardiac catheterization procedure
Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.
1 secondary outcome
Image quality assessment of the coronary angiogram
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
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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.
Vladimir Dzavik, MD, FRCPC principal investigator
UHN, Toronto, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiation: 15 FPS Cine 15 PPS, Radiation: 7.5 low Frame rate and Low Cine in people with Stable Angina and Unstable Angina, run by University Health Network, Toronto 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 3 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: status not confirmed, as of the sponsor's last update on 14 Oct 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Divyesh Sharma, MSc,MRCP (001-647-961-9336, divyeshsharma11@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Exposure to patient (time frame: During Cardiac catheterization procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2015.