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

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02574949
• Other study ID #: 15-8832-AE
• Status: Not yet recruiting
• Phase: N/A
• First received: May 26, 2015
• Last updated: October 13, 2015
• Start date: July 2015
• Est. completion date: July 2016

Study information

• Verified date: October 2015
• Source: University Health Network, Toronto
• Contact: Divyesh Sharma, MSc,MRCP
• Phone: 001-647-961-9336
• Email: divyeshsharma11[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Stable
• Angina, Unstable
• Stable Angina
• Unstable Angina

Intervention

Radiation:
• Radiation: 15 FPS Cine 15 PPS
Radiation 15 FPS Cine 15 PPS
• Radiation: 7.5 low Frame rate
Radiation: Frame rate 7.5 FPS, Cine 15 PPS
• Low Cine
Radiation: Frame rate 7.5 FPS, Cine 10 PPS

Locations

Country	Name	City	State
Canada	University Health Network - Peter Munk Cardiac Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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