Tin Filter Calcium Scoring

Not Applicable

Completed

• Conditions: Radiation Dose Reduction
• Interventions: Device: Tin Filter

• Registration Number: NCT02855528
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-08-01
• Study First Posted: 2016-08-04
• Primary Completion: 2017-11-14
• Study Completion: 2017-11-14
• Status Verified: 2018-03
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduction of radiation dose and diagnostic accuracy	Tin Filter	Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system.

Primary Outcome Measures

Name	Time	Method
Reduction in radiation dose using the new tin-filter system	2 years
Diagnostic accuracy of novel ultralow-dose non-enhanced coronary artery calcium scoring performed with the new tin filter system.	2 years

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States