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OpenTrials
Completed

NCT Number: NCT03605030

Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures

The primary objective of this study is to determine if a novel lead-based arm board is effective at reducing radiation dose to the operator during invasive cardiac procedures. Secondary objectives are to measure effect on radiation dose to patient and total fluoroscopy (x-ray) time.

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Key information

Conditions

Patients Undergoing Invasive Cardiac Procedures Radiation Exposure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age > 18
  • Planned invasive cardiology procedure, cardiac catheterization with or without percutaneous coronary intervention (PCI), or PCI alone.

Exclusion criteria

  • Inability to provide consent

Treatment and study plan

Novel Lead Based Armboard

Device

Novel Lead Based Armboard

Standard Armboard

Device

Standard Armboard (without lead)

Primary outcomes

  1. Radiation dose (μSv) to the operator at the chest

    Time frame: At procedure completion

    Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

  2. Radiation dose (μSv) to the operator at the forearm level

    Time frame: At procedure completion

    Co-primary outcomes included radiation dose (μSv; mean ± SD) to the operator at the chest and forearm level.

Secondary outcomes

  1. Air kerma

    Time frame: At procedure completion

  2. Dose area product

    Time frame: At procedure completion

  3. Radiation dose to the patient

    Time frame: At procedure completion

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre

Other

Collaborators

  • Western University, Canada

Registry information

Official study title

Reducing Radiation Exposure to Operators During Invasive Cardiac Procedures With a Novel Lead-Based Arm-Board

Acronym: RADAR

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 30, 2018
Registry last updated
Jul 30, 2018

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.

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