Clinical Trials Directory

Trials / Completed

CompletedNCT01990924

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
385 (actual)
Sponsor
Laval University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
RADIATION15 FPSX-ray pictures
RADIATION7.5 FPSX-ray pictures

Timeline

Start date
2012-10-01
Primary completion
2013-08-01
Completion
2013-08-01
First posted
2013-11-25
Last updated
2013-11-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01990924. Inclusion in this directory is not an endorsement.