Cardiac DiseaseCZTNCT02697760
The CZT Dynamic Myocardial Perfusion Imaging
An observational study of Cardiac Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- thallium-201
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Oct 2022
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with clinically suspected coronary artery disease, heart failure, or intermediate and high cardiovascular risks
Who may be able to join
- Coronary heart disease
- Clinical diagnosis of heart failure
- Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons.
Who cannot join
- Significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Quantification, Clinical Application of Dynamic Imaging Using Cadmium-zinc-telluride (CZT) Cameras to Assess Myocardial Perfusion
To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease.
Read the detailed description
Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations.
The present project aims to develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications.
- Conditions
- Cardiac Disease
- Being tested
- thallium-201
- Keywords
- cadmium-zinc-telluride，CZT cameras, myocardial blood flow，MBF, myocardial flow reserve，MFR
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thallium-201Radiation
Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronary artery disease (CAD) diagnosis
CAD defined as more than 50% stenosis in any vessel by coronary angiography or computed tomography.
Measured: 12 months after the index MPI
Secondary outcomes (1)
MACE (major adverse cardiac events)
revascularization, acute myocardial infarction, hospitalization for heart failure, cardiac death, non-cardiac death
Measured: 5 years after the index MPI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yen-Wen Wu, Far Eastern Memorial Hospital
- Investigators
- Yen-Wen Wu, MD, PhD, Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697760
- Sponsor's protocol ID
- 104069_F
- Acronym
- CZT
- Status last verified
- Oct 2022
- First submitted
- 27 Feb 2016
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quantification, Clinical Application of Dynamic Imaging Using Cadmium-zinc-telluride (CZT) Cameras to Assess Myocardial Perfusion
- ClinicalTrials.gov ID
- NCT02697760
- Acronym / sponsor ID
- CZT / 104069_F
- Conditions
- Cardiac Disease
- Keywords
- cadmium-zinc-telluride，CZT cameras, myocardial blood flow，MBF, myocardial flow reserve，MFR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 3 Mar 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.
To develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications in various heart disease.
Detailed description
Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) provide incremental diagnostic and prognostic information over relative perfusion alone. Recent development of dedicated cardiac SPECT cameras with better sensitivity and temporal resolution make dynamic SPECT imaging more practical. The potential roles of myocardial perfusion in subjects with cardiovascular risks and heart failure warrant further investigations.
The present project aims to develop and validate the noninvasive measurement of MBF and MFR by using dynamic imaging with a CZT camera, and evaluate the diagnostic and prognostic implications.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with clinically suspected coronary artery disease, heart failure, or intermediate and high cardiovascular risks
Key inclusion criteria (3 listed)
- Coronary heart disease
- Clinical diagnosis of heart failure
- Clinical diagnosis of metabolic diseases (such as metabolic syndrome, obesity, diabetes, hyperlipidemia, micro vascular diseases, etc.), heart failure or coronary heart disease in high-risk groups persons.
Key exclusion criteria (1 listed)
- Significant systemic disease (except heart disease) such as cirrhosis, end-stage renal disease or active malignancy, estimated life expectancy of less than three months, persons; pregnant or lactating women have the possibility of pregnancy.
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 |
|---|---|---|
| thallium-201Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging | Radiation | – |
Primary outcome
Coronary artery disease (CAD) diagnosis
Time frame: 12 months after the index MPI
CAD defined as more than 50% stenosis in any vessel by coronary angiography or computed tomography.
1 secondary outcome
MACE (major adverse cardiac events)
Time frame: 5 years after the index MPI
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 24 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Yen-Wen Wu, MD, PhD principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
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 1 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 24 Oct 2022. 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 Taiwan. 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?
Coronary artery disease (CAD) diagnosis (time frame: 12 months after the index MPI). 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 24 Oct 2022.