NCT02855528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2017

Completed
Last Updated

August 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2 years

First QC Date

July 28, 2016

Last Update Submit

July 31, 2018

Conditions

Radiation Dose Reduction

Keywords

Tin FilterCoronary Artery Calcium ScoringRadiation dose reduction

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Reduction of radiation dose and diagnostic accuracy

EXPERIMENTAL

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

Device: Tin Filter

Interventions

Tin FilterDEVICE
Reduction of radiation dose and diagnostic accuracy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Study Officials

  • Joseph U. Schoepf, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 4, 2016

Study Start

December 1, 2015

Primary Completion

November 14, 2017

Study Completion

November 14, 2017

Last Updated

August 2, 2018

Record last verified: 2018-03

Locations

US(1)