Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose
NCT ID: NCT02574949
Last Updated: 2015-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
600 participants
INTERVENTIONAL
2015-07-31
2016-07-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Conventional rate fluoroscopy
Radiation: 15 FPS Cine 15 PPS
Radiation: 15 FPS Cine 15 PPS
Radiation 15 FPS Cine 15 PPS
Intermediate frame rate 7.5 fps
Radiation: 7.5 low Frame rate
Radiation: 7.5 low Frame rate
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Low frame rate
Low Cine 10 PPS
Low Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
Interventions
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Radiation: 15 FPS Cine 15 PPS
Radiation 15 FPS Cine 15 PPS
Radiation: 7.5 low Frame rate
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Low Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients participating in other research study requiring higher cine angiography.
* ST-elevation Myocardial Infarction
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Vladimír Džavík
Director of Research and Innovation-Interventional Cardiology and Coronary Intensive Care Unit
Principal Investigators
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Vladimir Dzavik, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
UHN, Toronto, Canada
Locations
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University Health Network - Peter Munk Cardiac Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Other Identifiers
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15-8832-AE
Identifier Type: -
Identifier Source: org_study_id
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