Coronary Artery DiseaseNCT02469051
Breath-hold Cardiac Hybrid SPECT/CCTA
A study testing Breathhold SPECT-MPI, Standard freebreathing SPECT-MPI and Coronary CT angiography in people with Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
Trial summary
This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Breathhold SPECT-MPI, Standard freebreathing SPECT-MPI and Coronary CT angiography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Nuclear Medicine, University Hospital Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging
This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.
- Conditions
- Coronary Artery Disease
- Being tested
- Breathhold SPECT-MPI, Standard freebreathing SPECT-MPI, Coronary CT angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathhold SPECT-MPIDevice
Respiratory triggered SPECT myocardial perfusion imaging
Standard freebreathing SPECT-MPIDevice
Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging
Coronary CT angiographyDevice
Also called CCTA
Clinically indicated coronary CT angiography serving as standard of reference
| Study group | Role | What they receive |
|---|---|---|
| Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI | Other | Not described Receives: Device: Breathhold SPECT-MPI; Device: Standard freebreathing SPECT-MPI; Device: Coronary CT angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image quality as visually assessed on a Likert scale
Measured: 1 day
Number of image artefacts
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469051
- Sponsor's protocol ID
- USZ-2015-0098
- Status last verified
- May 2016
- First submitted
- 13 May 2015
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usefulness of Breath-hold Triggered SPECT-MPI in Cardiac Hybrid SPECT/CCTA Imaging
- ClinicalTrials.gov ID
- NCT02469051
- Acronym / sponsor ID
- USZ-2015-0098
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims at combining inspiration breath-hold myocardial perfusion SPECT with coronary CT angiography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI | Other | Device: Breathhold SPECT-MPI, Device: Standard freebreathing SPECT-MPI, Device: Coronary CT angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathhold SPECT-MPIRespiratory triggered SPECT myocardial perfusion imaging | Device | Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI |
| Standard freebreathing SPECT-MPIClinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging | Device | Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI |
| Coronary CT angiographyAlso: CCTAClinically indicated coronary CT angiography serving as standard of reference | Device | Breathhold SPECT-MPI vs. standard freebreathing SPECT-MPI |
Primary outcome
Image quality as visually assessed on a Likert scale
Time frame: 1 day
Number of image artefacts
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathhold SPECT-MPI, Standard freebreathing SPECT-MPI and Coronary CT angiography in people with Coronary Artery Disease, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image quality as visually assessed on a Likert scale (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.