Impact of Low Frame Rate Fluoroscopy and Cine-angiography on Reducing Operator and Patient Dose

Not Applicable

• Conditions: Acute Coronary Syndrome; Unstable Angina; Stable Angina
• Interventions: Radiation: Low Cine

• Registration Number: NCT02574949
• Lead Sponsor: University Health Network, Toronto

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.

Study Timeline

• Study First Submitted: 2015-05-26
• Study Start: 2015-07
• Status Verified: 2015-10
• Study First Submitted QC: 2015-10-13
• Last Update Submitted: 2015-10-13
• Study First Posted: 2015-10-14
• Last Update Posted: 2015-10-14
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low frame rate	Low Cine	Low Cine 10 PPS

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Health Network - Peter Munk Cardiac Centre; 🇨🇦 Toronto, Ontario, Canada