Ultra Low Dose CT for CACS and AC of SPECT

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Ultra low dose non-contrast enhanced CT; Device: Standard dose non-contrast enhanced CT

• Registration Number: NCT02458352
• Lead Sponsor: University of Zurich

Brief Summary

The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-08
• Study First Submitted QC: 2015-05-27
• Study First Posted: 2015-06-01
• Study Start: 2015-11
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2018-06-18
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-25
• Last Update Submitted: 2019-09-25
• Results First Posted: 2019-10-18
• Last Update Posted: 2019-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• Patients referred for myocardial perfusion SPECT
• Male and Female subjects ≥18 years of age,
• Written informed consent

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Exclusion Criteria

• Pregnancy or breast-feeding
• CACS of 0 after inclusion of 10 patients with CACS 0
• Stents or implanted cardiac devices (valves, pace makers, ICD)
• Coronary artery bypass grafts

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Standard dose CT, Ultra-low dose CT	Standard dose non-contrast enhanced CT	Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)
Standard dose CT, Ultra-low dose CT	Ultra low dose non-contrast enhanced CT	Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)

Primary Outcome Measures

Name	Time	Method
Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT	1 days	CAC and BA limits of agreement between coronary artery calcium score obtained from ultra-low-dose and standard CT.; Coronary artery calcium (CAC) is a measure for quantification of coronary artery calcification based on non-contrast enhanced CT, ranging from 0 (no calcifications) to infinite. It is an arbitrary unit. Increasing CAC means higher amounts of coronary artery calcifications and is associated with worse prognosis.; Bland-Altman (BA) analysis is a statistical method to compare two modalities or techniques assessing the same measure. Limits of agreement is defined as +/- twice the standard deviation of the differences between the reference method and the new modality/technique. Broader limits of agreement mean less accurate results obtained by the new modality/techniqe, while a 0 BA limit of agreement would theoretically reflect perfect agreement.
Intra-class Correlation Coefficient Between Segmental Relative Tracer Uptake From SPECT Datasets Reconstructed With AC Maps Based on Ultra-Low-Dose and Standard Dose CT	1 day	For every patient, the CT images from 120 and 70 kVp-CT scans were used to create CTAC maps which were then used to reconstruct SPECT images, displayed as a 17-segment model polar plot with normalized percent tracer uptake given for every segment. Intra-class correlation was then applied to compare segmental relative tracer uptake. Analysis and the resulting correlation coefficient of 0.987 basically demonstrates interchangeability between the two datasets.

Trial Locations

Locations (1)

Department of Nuclear Medicine, University Hospital Zurich; 🇨🇭 Zurich, Switzerland