An interventional study of Radiation: 15 FPS Cine 15 PPS and Radiation: 7.5 low Frame rate in Stable Angina, Unstable Angina and Acute Coronary Syndrome, sponsored by University Health Network, Toronto. Status unknown at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-14.
Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Health services research
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.
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.
1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.
This study's planned enrollment of 600 is above the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
Radiation: 15 FPS Cine 15 PPS
Radiation: Radiation: 15 FPS Cine 15 PPS
Radiation: 7.5 low Frame rate
Radiation: Radiation: 7.5 low Frame rate
Low Cine 10 PPS
Radiation: Low Cine
Radiation 15 FPS Cine 15 PPS
Also known as: Conventional
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
Also known as: Low rate fluoroscopy
Radiation: Frame rate 7.5 FPS, Cine 10 PPS
Also known as: Low pulse rate Cine
Radiation Exposure to patient
Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.
Time frame: During Cardiac catheterization procedure
Image quality assessment of the coronary angiogram
Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool
Time frame: 12 months
This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto