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Completed

NCT Number: NCT02855528

Tin Filter Calcium Scoring

The aim of this study is to prospectively investigate the diagnostic performance and potential radiation dose reduction in coronary artery calcium scoring using the new tin filter system of the 3rd generation DSCT scanner.

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Key information

Conditions

Radiation Dose Reduction

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject must be between 19-90 years of age.
  • Subject must have been referred for a clinically indicated coronary artery calcium scan and/or coronary CT angiography or TRO scan with coronary artery calcium scoring.
  • Subject must provide written informed consent prior to any study-related procedures being performed.
  • Subject must be willing to comply with all clinical study procedures.

Exclusion criteria

  • Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
  • By testing (urine BHCG) within 24 hours before scan, or
  • By surgical sterilization, or
  • Post menopausal, with minimum one (1) year history without menses.
  • Subject has an acute psychiatric disorder or is cognitively impaired.
  • Subject is using or is dependent on substances of abuse.
  • Subject is unwilling to comply with the requirements of the protocol.
  • Subject is in acute unstable condition.

Treatment and study plan

Tin Filter

Device

Primary outcomes

  1. Reduction in radiation dose using the new tin-filter system

    Time frame: 2 years

  2. Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Ultra Low-dose Coronary Artery Calcium Scoring Using Tin Filtration With Dual-source CT

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 4, 2016
Registry last updated
Aug 2, 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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