Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose
Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Radiation Dose and Impact on Image Quality During Cardiac Catheterization
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ontario
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Toronto, Ontario, Canada
- University Health Network - Peter Munk Cardiac Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients undergoing elective or urgent cardiac catheterisation with or without ad-hoc PCI or planned PCI in the pre-specified catheterisation laboratories.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional rate fluoroscopy
Radiation: 15 FPS Cine 15 PPS
|
Radiation 15 FPS Cine 15 PPS
Other Names:
|
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Experimental: Intermediate frame rate 7.5 fps
Radiation: 7.5 low Frame rate
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Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Other Names:
|
|
Experimental: Low frame rate
Low Cine 10 PPS
|
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
During Cardiac catheterization procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Image quality assessment of the coronary angiogram
Time Frame: 12 months
|
Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vladimir Dzavik, MD, FRCPC, UHN, Toronto, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-8832-AE
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