Tin Filter Calcium Scoring

NCT ID: NCT02855528

Last Updated: 2018-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-11-14

Brief Summary

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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

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Conditions

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Radiation Dose Reduction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Reduction of radiation dose and diagnostic accuracy

Reduction of radiation dose during coronary artery calcium scoring with the use of a tin filter system.

Group Type EXPERIMENTAL

Tin Filter

Intervention Type DEVICE

Interventions

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Tin Filter

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph U. Schoepf, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00051523

Identifier Type: -

Identifier Source: org_study_id

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