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

University Health Network, Toronto

Status: Unknown

Conditions: Unstable Angina; Acute Coronary Syndrome; Stable Angina

Treatments: Radiation: Low Cine; Radiation: Radiation: 15 FPS Cine 15 PPS; Radiation: Radiation: 7.5 low Frame rate

Study type: Interventional

Funder types: Other

Identifiers

NCT02574949

15-8832-AE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Conventional rate fluoroscopy

Active Comparator group

Description:

Radiation: 15 FPS Cine 15 PPS

Treatment:

Radiation: Radiation: 15 FPS Cine 15 PPS

Intermediate frame rate 7.5 fps

Experimental group

Description:

Radiation: 7.5 low Frame rate

Treatment:

Radiation: Radiation: 7.5 low Frame rate

Low frame rate

Experimental group

Description:

Low Cine 10 PPS

Treatment:

Radiation: Low Cine