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

Not Applicable

Completed

• Conditions: Stable Angina; Unstable Angina; Acute Coronary Syndrome
• Interventions: Radiation: 7.5 FPS; Radiation: 15 FPS

• Registration Number: NCT01990924
• Lead Sponsor: Laval University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Study First Submitted: 2013-11-07
• Study First Submitted QC: 2013-11-18
• Last Update Submitted: 2013-11-18
• Study First Posted: 2013-11-25
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
7.5 FPS	7.5 FPS	Low rate fluoroscopy at 7.5 frames per second (FPS)
15 FPS	15 FPS	Conventional rate fluoroscopy at 15 FPS

Primary Outcome Measures

Name	Time	Method
Radiation Exposure	During Cardiac Catheterization	Fluoroscopy time

Secondary Outcome Measures

Name	Time	Method
Procedural Characteristics	During Cardiac Catheterization	Total contrast volume used

Trial Locations

Locations (1)

IUCPQ - Laval Hospital; 🇨🇦 Quebec, Canada