Ultra Low Dose CT for CACS and AC of SPECT
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Ultra low dose non-contrast enhanced CT
Standard dose non-contrast enhanced CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Department of Nuclear Medicine, University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Standard dose CT, Ultra-low dose CT
Arm Description
Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02458352
Brief Title
Ultra Low Dose CT for CACS and AC of SPECT
Official Title
Usefulness of Ultra Low Dose Cardiac CT for Coronary Calcium Scoring and for Attenuation Correction of SPECT
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard dose CT, Ultra-low dose CT
Arm Type
Other
Arm Description
Standard dose non-contrast enhanced CT (clinically indicated) and Ultra low dose non-contrast enhanced CT (as part of the trial)
Intervention Type
Device
Intervention Name(s)
Ultra low dose non-contrast enhanced CT
Intervention Description
Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure
Intervention Type
Device
Intervention Name(s)
Standard dose non-contrast enhanced CT
Intervention Description
Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol
Primary Outcome Measure Information:
Title
Agreement and Correlation of Coronary Artery Calcium Score Obtained From Ultra-low-dose and Standard CT
Description
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.
Time Frame
1 days
Title
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
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Treyer, PhD
Organizational Affiliation
University of Zurich
Official's Role
Study Director
Facility Information:
Facility Name
Department of Nuclear Medicine, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
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Ultra Low Dose CT for CACS and AC of SPECT
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