Skip to main content
OpenTrials
Completed

NCT Number: NCT01990924

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stable Angina Acute Coronary Syndrome Angina Pectoris Angina, Stable Angina, Unstable Cardiovascular Diseases Chest Pain Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Unstable Angina Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IUCPQ - Laval Hospital

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

15 FPS

Radiation

X-ray pictures

Other names: Standard practice, conventional 15 frames per second (FPS)

7.5 FPS

Radiation

X-ray pictures

Other names: Low rate fluoroscopy at 7.5 FPS

Primary outcomes

  1. Radiation Exposure

    Time frame: During Cardiac Catheterization

    Operator radiation dose (measured with dosimeter attached to the left side of thyroid shield, in µSv)

  2. Radiation Exposure

    Time frame: During Cardiac Catheterization

    Patient radiation dose (expressed as dose-area product [DAP] in μGy.m2)

  3. Radiation Exposure

    Time frame: During Cardiac Catheterization

    Fluoroscopy time

Secondary outcomes

  1. Procedural Characteristics

    Time frame: During Cardiac Catheterization

    Procedural duration

  2. Procedural Characteristics

    Time frame: During Cardiac Catheterization

    Total contrast volume used

Sponsors and collaborators

Lead sponsor

Laval University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 25, 2013
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.