Low Rate Fluoroscopy to Reduce Radiation Dose During Coronary Angiography and Intervention

Laval University

Status: Completed

Conditions: Unstable Angina; Acute Coronary Syndrome; Stable Angina

Treatments: Radiation: 7.5 FPS; Radiation: 15 FPS

Study type: Interventional

Funder types: Other

Identifiers

NCT01990924

7.5 vs 15 (Other Identifier)

7.5 vs 15 Cine

Details and patient eligibility

About

Objectives: To determine the efficacy of low rate fluoroscopy at 7.5 frames per second (FPS) vs. conventional 15 FPS for reduction of operator and patient radiation dose during diagnostic coronary angiography and percutaneous coronary intervention via the transradial approach.

Background: Transradial approach for cardiac catheterization is potentially associated with increased radiation exposure. Low rate fluoroscopy has potential to reduce radiation exposure.

Full description

Methods: Patients undergoing transradial approach diagnostic angiography ± ad hoc PCI, wil be randomized to fluoroscopy at 7.5 FPS vs. 15 FPS prior to procedure. Both 7.5 and 15 FPS fluoroscopy protocols will be configured with a fixed dose per pulse of 40 nGy. Primary endpoints will be operator radiation dose (measured with dosimeter attached to the left side of thyroid shield in µSv), patient radiation dose (expressed as dose-area product in μGy.m2), and fluoroscopy time.

Enrollment: 385 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing elective, urgent or emergent cardiac catheterization procedures with or without ad hoc PCI, via transradial approach are eligible.

Exclusion criteria

• 1. non-transradial access and 2) participation in research project(s) requiring higher ie 30 FPS cine angiography.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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385 participants in 2 patient groups

7.5 FPS

Experimental group

Description:

Low rate fluoroscopy at 7.5 frames per second (FPS)

Treatment:

Radiation: 7.5 FPS

15 FPS

Active Comparator group

Description:

Conventional rate fluoroscopy at 15 FPS

Treatment:

Radiation: 15 FPS