Tin Filter Calcium Scoring

Medical University of South Carolina149 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

149

Conditions

Radiation Dose Reduction

Interventions

Tin FilterDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Medical University of South Carolina

Charleston, South Carolina, United States

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

Data from ClinicalTrials.gov

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