Clinical trial NCT02574949: Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stable Angina
Unstable Angina
Acute Coronary Syndrome
Keywords: radiation
fluoroscopy
diagnostic
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-10-14
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation Exposure to patient
timeFrame: During Cardiac catheterization procedure
Secondary outcomes:
measure: Image quality assessment of the coronary angiogram
timeFrame: 12 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network - Peter Munk Cardiac Centre
state: Ontario
Study officials:
affiliation: UHN, Toronto, Canada
name: Vladimir Dzavik, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: