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Clinical Trials/NCT02855528
NCT02855528
Completed
Not Applicable

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

Medical University of South Carolina1 site in 1 country149 target enrollmentDecember 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Radiation Dose Reduction
Sponsor
Medical University of South Carolina
Enrollment
149
Locations
1
Primary Endpoint
Reduction in radiation dose using the new tin-filter system
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2015
End Date
November 14, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Reduction in radiation dose using the new tin-filter system

Time Frame: 2 years

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

Time Frame: 2 years

Study Sites (1)

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