Ultra Low Dose CT for CACS and AC of SPECT

Coronary Artery Disease Clinical Trial

Official title:

Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02458352
• Other study ID #: USZ-2015-0072
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: October 2016

Study information

• Verified date: September 2019
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients referred for myocardial perfusion SPECT

• Male and Female subjects =18 years of age,

• Written informed consent

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Ultra low dose non-contrast enhanced CT
Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure
• Standard dose non-contrast enhanced CT
Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol

Locations

Country	Name	City	State
Switzerland	Department of Nuclear Medicine, University Hospital Zurich	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT	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.	1 days
Primary	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	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.	1 day