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

Acute Coronary Syndrome Clinical Trial

Official title:

Low Rate Fluoroscopy at Reducing Operator and Patient Radiation Dose During Transradial Coronary Diagnostic Angiography and Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01990924
• Other study ID #: 7.5 vs 15 Cine
• Secondary ID: 7.5 vs 15
• Status: Completed
• Phase: N/A
• First received: November 7, 2013
• Last updated: November 18, 2013
• Start date: October 2012
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 385
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: 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:
• 15 FPS
X-ray pictures
• 7.5 FPS
X-ray pictures

Locations

Country	Name	City	State
Canada	IUCPQ - Laval Hospital	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Exposure	Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)	During Cardiac Catheterization	Yes
Primary	Radiation Exposure	Patient radiation dose (expressed as dose-area product [DAP] in µGy.m2)	During Cardiac Catheterization	Yes
Primary	Radiation Exposure	Fluoroscopy time	During Cardiac Catheterization	Yes
Secondary	Procedural Characteristics	Procedural duration	During Cardiac Catheterization	Yes
Secondary	Procedural Characteristics	Total contrast volume used	During Cardiac Catheterization	Yes