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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
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 8, 2015
Last Updated
September 25, 2019
Sponsor
University of Zurich
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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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