Tin Filter Calcium Scoring

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Radiation Dose Reduction

Treatments: Device: Tin Filter

Study type: Interventional

Funder types: Other

Identifiers

NCT02855528

Pro00051523

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

Reduction of radiation dose and diagnostic accuracy

Experimental group

Description:

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

Treatment:

Device: Tin Filter