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

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.

Study Overview

• Status: Unknown
• Conditions: Acute Coronary Syndrome; Stable Angina; Unstable Angina
• Intervention / Treatment: Radiation: Radiation: 15 FPS Cine 15 PPS; Radiation: Radiation: 7.5 low Frame rate; Radiation: Low Cine

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 Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • University Health Network - Peter Munk Cardiac Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional rate fluoroscopy; Radiation: 15 FPS Cine 15 PPS	Radiation: Radiation: 15 FPS Cine 15 PPS; Radiation 15 FPS Cine 15 PPS; Other Names: Conventional
Experimental: Intermediate frame rate 7.5 fps; Radiation: 7.5 low Frame rate	Radiation: Radiation: 7.5 low Frame rate; Radiation: Frame rate 7.5 FPS, Cine 15 PPS; Other Names: Low rate fluoroscopy
Experimental: Low frame rate; Low Cine 10 PPS	Radiation: Low Cine; Radiation: Frame rate 7.5 FPS, Cine 10 PPS; Other Names: Low pulse rate Cine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiation Exposure to patient	Radiation exposure to patient will be measured by Dose-Area product (DAP) collected during the procedure.	During Cardiac catheterization procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Vladimir Dzavik, MD, FRCPC, UHN, Toronto, Canada

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Estimate): October 14, 2015
• Last Update Submitted That Met QC Criteria: October 13, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: radiation; diagnostic; fluoroscopy
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Angina, Unstable
• Other Study ID Numbers: 15-8832-AE