Quantitative Analysis of SPECT MPINCT02985931
Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification
An observational study of Quantitative Analysis of SPECT MPI, run by Chang Gung Memorial Hospital.
Trial summary
The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Quantitative Analysis of SPECT MPI
- What is being tested?
- Diagnostic imaging scans of SPECT and MRI
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- May 2012to May 2015
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are suspected with coronary artery diseases and need imaging exams.
Who may be able to join
- Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
- > 20 years old.
- Not under infection or other conditions inappropriate for being recruited.
- Without myocardial infarction within one week.
- With stable blood pressure.
- Subjects with normal kidney functions and without allergic reactions to MRI contrast agents.
Who cannot join
- Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
- Pregnant subjects or subjects who are currently breast-feeding.
- Those currently under radiation therapies.
- Patients with pleural effusion.
- Patients who are allergic to SPECT tracers.
- Patients with serious psychological disorders.
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- Patients with asthma.
- Patients with stroke within a week.
- Patients with AV block.
- Patients with sinus syndrome.
- Subjects who are currently under other clinical trials.
- Subjects with poor kidney functions who are inappropriate for MRI contrast agents.
- Subjects with pacemakers.
- Subjects with Claustrophobia.
- Subjects who cannot hold breath for cardiac MRI studies.
About this study
The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. The investigators will use kinetic modeling techniques to design a study that allows the absolute flow quantification. To make this study practical, the investigators will develop a protocol that includes the acquisition of both the rest and stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow will be validated against the flow measured with cardiac MRI scans. Patients with high CAD risk will be recruited for the clinical trial. Data from these human subjects will be used for determination of the performance of the developed algorithm. With the proposed rapid scan with absolute quantification capabilities, the investigators expect to increase the diagnosis accuracy while maintaining the patient throughput.
- Conditions
- Quantitative Analysis of SPECT MPI
- Being tested
- Diagnostic imaging scans of SPECT and MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic imaging scans of SPECT and MRIOther
| Study group | Role | What they receive |
|---|---|---|
| Suspected CAD subjects | Not described Receives: Other: Diagnostic imaging scans of SPECT and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between SPECT- and MRI-measured flow values
Measured: through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startMay 2012
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quantitative Analysis of SPECT MPIStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tzu-Chen Yen, Chang Gung Memorial Hospital
- Investigators
- Tzu-Chen Yen, MD, PhD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985931
- Sponsor's protocol ID
- 101-0453A3
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-scan Rest/Stress Imaging With Cadmium Zinc Telluride-based SPECT for Coronary Flow Quantification
- ClinicalTrials.gov ID
- NCT02985931
- Acronym / sponsor ID
- 101-0453A3
- Conditions
- Quantitative Analysis of SPECT MPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Dec 2016 (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.
The investigators aim to address this issue with novel image quantification methods using CZT-based SPECT, which is capable of dynamic data acquisition and therefore feasible for the quantification of the coronary flow. The investigators will use kinetic modeling techniques to design a study that allows the absolute flow quantification. To make this study practical, the investigators will develop a protocol that includes the acquisition of both the rest and stress scan within the same scan that is shorter than 30 minutes. The SPECT-measured flow will be validated against the flow measured with cardiac MRI scans. Patients with high CAD risk will be recruited for the clinical trial. Data from these human subjects will be used for determination of the performance of the developed algorithm. With the proposed rapid scan with absolute quantification capabilities, the investigators expect to increase the diagnosis accuracy while maintaining the patient throughput.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected CAD subjects | – | Other: Diagnostic imaging scans of SPECT and MRI |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are suspected with coronary artery diseases and need imaging exams.
Key inclusion criteria (6 listed)
- Subjects with high possibility of coronary artery disease after being evaluated by a cardiologist.
- > 20 years old.
- Not under infection or other conditions inappropriate for being recruited.
- Without myocardial infarction within one week.
- With stable blood pressure.
Key exclusion criteria (15 listed)
- Subjects who cannot take a SPECT scan or do not agree to sign the informed consent.
- Pregnant subjects or subjects who are currently breast-feeding.
- Those currently under radiation therapies.
- Patients with pleural effusion.
- Patients who are allergic to SPECT tracers.
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 |
|---|---|---|
| Diagnostic imaging scans of SPECT and MRI | Other | Suspected CAD subjects |
Primary outcome
Correlation between SPECT- and MRI-measured flow values
Time frame: through study completion, an average of 3 year
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 7 Dec 2016.
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.
Tzu-Chen Yen, MD, PhD principal investigator
Chang Gung Memorial Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Quantitative Analysis of SPECT MPI, run by Chang Gung Memorial Hospital.
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 6 inclusion and 15 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 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Correlation between SPECT- and MRI-measured flow values (time frame: through study completion, an average of 3 year). 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 7 Dec 2016.