Coronary Artery DiseaseNCT06030596
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
An observational study of Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2022to 4 Dec 2023
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Suspected or known CAD
Who may be able to join
- Age 18 ~ 79 years old
- At least one CAD risk factor
- Intermediate to high pre-test likelihood for CAD
- Suspected or known CAD, clinically referred for invasive coronary angiography
- Able and willing to comply with the study procedures
- Written informed consent
Who cannot join
- History or risk of severe bradycardia
- History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
- Wheezing asthma or COPD
- Known second- or third-degree AV block
- Known hypersensitivity to dipyridamole or adenosine
- Known coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) prior to screening
Show all 9Show fewer
- Breastfeeding or pregnancy
- Claustrophobia or inability to lie still in a supine position
- Unwillingness or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic performance for quantitative SPECT has not been validated using fractional flow reserve (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR results as the reference standard in patients with suspected or known CAD.
- Conditions
- Coronary Artery Disease
- Keywords
- SPECT, Myocardial Blood Flow, Myocardial Flow Reserve
- 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.
| Study group | Role | What they receive |
|---|---|---|
| coronary artery disease | Suspected or known coronary artery disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnostic accuracy of MBF and MFR derived from SPECT
The diagnostic sensitivity, specificity, accuracy of MBF and MFR derived from SPECT for the detection of hemodynamically significant coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start9 Sep 2022
- Primary completion1 Dec 2023
- Study completion4 Dec 2023
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 China National Center for Cardiovascular DiseasesThe 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
- 202 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wei Fang, China National Center for Cardiovascular Diseases
- Investigators
- Wei Fang, MD/PhD, Study chair, Fuwai Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030596
- Sponsor's protocol ID
- SPECT MBFQ Trial II
- Status last verified
- Nov 2026
- First submitted
- 31 Aug 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
- ClinicalTrials.gov ID
- NCT06030596
- Acronym / sponsor ID
- SPECT MBFQ Trial II
- Conditions
- Coronary Artery Disease
- Keywords
- SPECT, Myocardial Blood Flow, Myocardial Flow Reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 4 Dec 2023 (actual)
- First posted
- 11 Sep 2023 (actual)
- 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.
Recent evidences have demonstrated improved diagnostic accuracy for detecting coronary artery disease (CAD) when myocardial blood flow (MBF) is quantified in absolute terms using single photon emission tomography (SPECT) compared to conventional myocardial perfusion imaging (MPI). However, there are no uniformly accepted cutoff values of MBF and MFR derived from SPECT for diagnosing hemodynamically significant CAD. Particularly, the diagnostic performance for quantitative SPECT has not been validated using fractional flow reserve (FFR). The aim of this prospective study is to determine optimal cutoff values of absolute MBF and MFR derived from NaI (Tl)-based SPECT and to evaluate the diagnostic efficacy of this quantitative technology utilizing invasive coronary angiography (ICA) in combination with FFR results as the reference standard in patients with suspected or known CAD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery disease | – | –Suspected or known coronary artery disease |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Suspected or known CAD
Key inclusion criteria (6 listed)
- Age 18 ~ 79 years old
- At least one CAD risk factor
- Intermediate to high pre-test likelihood for CAD
- Suspected or known CAD, clinically referred for invasive coronary angiography
- Able and willing to comply with the study procedures
Key exclusion criteria (9 listed)
- History or risk of severe bradycardia
- History of myocardial infarction, dilated cardiomyopathy, hypertrophic cardiomyopathy, valve issue or congenital heart disease
- Wheezing asthma or COPD
- Known second- or third-degree AV block
- Known hypersensitivity to dipyridamole or adenosine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The diagnostic accuracy of MBF and MFR derived from SPECT
Time frame: 1 year
The diagnostic sensitivity, specificity, accuracy of MBF and MFR derived from SPECT for the detection of hemodynamically significant coronary artery disease as defined by invasive coronary angiography in combination with fractional flow reserve measurements.
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 4 Nov 2026.
- 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.
Wei Fang, MD/PhD study chair
Fuwai Hospital, Beijing, China
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 Coronary Artery Disease, run by China National Center for Cardiovascular Diseases at 1 site in China.
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 9 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 4 Nov 2026. 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 China. 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?
The diagnostic accuracy of MBF and MFR derived from SPECT (time frame: 1 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 4 Nov 2026.