Acute Coronary Syndrome, Stable Angina, Unstable Angina
Conditions
Keywords
radiation, fluoroscopy, diagnostic
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.
Interventions
RADIATIONRadiation: 15 FPS Cine 15 PPS
Radiation 15 FPS Cine 15 PPS
RADIATIONRadiation: 7.5 low Frame rate
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
RADIATIONLow Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiation Exposure to patient | During Cardiac catheterization procedure | Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Image quality assessment of the coronary angiogram | 12 months | Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool |
Countries
Canada
Contacts
Primary ContactDivyesh Sharma, MSc,MRCP
Backup ContactAshish H Shah, MD, MD(Res)
Outcome results
None listed