Acute Coronary Syndrome Clinical Trial
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
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network - Peter Munk Cardiac Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiation Exposure to patient | Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure. | During Cardiac catheterization procedure | Yes |
Secondary | Image quality assessment of the coronary angiogram | Coronary angiograms will be assessed by blinded operators for quality of image using a pre-specified tool | 12 months | No |
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