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

November 18, 2013 updated by: Olivier F. Bertrand, Laval University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

385

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G5
        • IUCPQ - Laval Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 7.5 FPS
Low rate fluoroscopy at 7.5 frames per second (FPS)
Radiation: 7.5 FPS
X-ray pictures
Other Names:
  • Low rate fluoroscopy at 7.5 FPS
Active Comparator: 15 FPS
Conventional rate fluoroscopy at 15 FPS
Radiation: 15 FPS
X-ray pictures
Other Names:
  • Standard practice, conventional 15 frames per second (FPS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation Exposure
Time Frame: During Cardiac Catheterization
Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)
During Cardiac Catheterization
Radiation Exposure
Time Frame: During Cardiac Catheterization
Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)
During Cardiac Catheterization
Radiation Exposure
Time Frame: During Cardiac Catheterization
Fluoroscopy time
During Cardiac Catheterization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedural Characteristics
Time Frame: During Cardiac Catheterization
Procedural duration
During Cardiac Catheterization
Procedural Characteristics
Time Frame: During Cardiac Catheterization
Total contrast volume used
During Cardiac Catheterization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laval University

Investigators

  • Study Chair: Olivier F Bertrand, MD PhD, International Chair on Interventional Cardiology and Transradial Approach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

November 7, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7.5 vs 15 Cine
  • 7.5 vs 15 (Other Identifier: ICICTA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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