Back to resultsBreath-hold Cardiac Hybrid SPECT/CCTA
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Breathhold SPECT-MPI
Standard freebreathing SPECT-MPI
Coronary CT angiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Referral for cardiac hybrid SPECT/CCTA
- Male and female subjects 18 years of age or older
- Written informed consent by the participant after information about the project
Exclusion Criteria:
- Contraindications for coronary CT angiography (including renal failure with a GFR <30ml/min/1.73m2, allergies to iodinated contrast agents)
- Pregnancy or breast-feeding
- Previous coronary revascularisation
- Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc
Sites / Locations
- Department of Nuclear Medicine, University Hospital Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI
Arm Description
Outcomes
Primary Outcome Measures
Image quality as visually assessed on a Likert scale
Number of image artefacts
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02469051
Brief Title
Breath-hold Cardiac Hybrid SPECT/CCTA
Official Title
Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 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
This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.
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
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Breathhold SPECT-MPI
Intervention Description
Respiratory triggered SPECT myocardial perfusion imaging
Intervention Type
Device
Intervention Name(s)
Standard freebreathing SPECT-MPI
Intervention Description
Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging
Intervention Type
Device
Intervention Name(s)
Coronary CT angiography
Other Intervention Name(s)
CCTA
Intervention Description
Clinically indicated coronary CT angiography serving as standard of reference
Primary Outcome Measure Information:
Title
Image quality as visually assessed on a Likert scale
Time Frame
1 day
Title
Number of image artefacts
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referral for cardiac hybrid SPECT/CCTA
Male and female subjects 18 years of age or older
Written informed consent by the participant after information about the project
Exclusion Criteria:
Contraindications for coronary CT angiography (including renal failure with a GFR <30ml/min/1.73m2, allergies to iodinated contrast agents)
Pregnancy or breast-feeding
Previous coronary revascularisation
Inability to follow the examination procedure (e.g. due to language barriers, severe mental disease etc
Facility Information:
Facility Name
Department of Nuclear Medicine, University Hospital Zurich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Breath-hold Cardiac Hybrid SPECT/CCTA
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