Coronary Artery DiseaseNCT06980194
A Head-to-Head Comparison of A New Perfusion Tracer, 99mTc-4BOH vs. 13N-NH3 to Evaluate Diagnostic Efficacy of Ischemic Heart Disease
A study testing 99mTc-4BOH SPECT myocardial perfusion imaging and 13N-ammonia PET myocardial perfusion imaging in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.
Trial summary
The objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of 99mTc-4BOH SPECT myocardial perfusion imaging (MPI) compared to 13N-ammonia PET MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- 99mTc-4BOH SPECT myocardial perfusion imaging and 13N-ammonia PET myocardial perfusion imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years. Presence of angina symptoms, such as chest tightness or chest pain. Coronary CT angiography (CTA) indicating ≥50% stenosis in at least one coronary artery.
- Able and willing to provide written informed consent.
Who cannot join
- Underwent coronary revascularization (PCI or CABG) within the past 6 months. Presence of non-ischemic heart disease or left ventricular ejection fraction (LVEF) <35%.
- Contraindications to adenosine stress (e.g., bronchial asthma, second-degree or higher atrioventricular block, severe hypotension).
- Pregnancy or lactation. Unable or unwilling to sign the informed consent form.
About this study
Official title: A Prospective, Single-Center, Head-to-Head Clinical Trial Comparing 99mTc-4BOH SPECT Myocardial Perfusion Imaging With 13N-Ammonia PET Imaging for the Diagnosis of Myocardial Ischemia, Using Invasive Coronary Angiography and Fractional Flow Reserve as the Reference Standard
The objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of 99mTc-4BOH SPECT myocardial perfusion imaging (MPI) compared to 13N-ammonia PET MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA).
Read the detailed description
The goal of this trial is to evaluate whether SPECT myocardial perfusion using the novel tracer 99mTc-4BOH is non-inferior to 13N-ammonia PET in diagnosing myocardial ischemia in patients with fractional flow reserve (FFR) as the diagnostic gold standard. In this study, 13N-ammonia PET imaging will be used as the positive control. Patients with diagnosed CAD who are scheduled for myocardial perfusion imaging will be assigned to undergo head-to-head SPECT imaging with 99mTc-4BOH and PET imaging with 13N-ammonia, with no more than 7 days between scans. All participants will subsequently undergo coronary angiography with FFR measurement within 30 days of imaging. The diagnostic performance of 99mTc-4BOH will be compared to that of 13N-ammonia, using FFR as the reference standard.
- Conditions
- Coronary Artery Disease
- Being tested
- 99mTc-4BOH SPECT myocardial perfusion imaging, 13N-ammonia PET myocardial perfusion imaging
- Keywords
- myocardial blood flow quantification, novel SPECT tracer, myocardial perfusion imaging
- 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.
99mTc-4BOH SPECT myocardial perfusion imagingDiagnostic test
Participants undergo myocardial perfusion imaging using the investigational radiotracer 99mTc-4BOH with SPECT. Imaging is performed according to a standardized protocol. Each participant receives both this SPECT imaging and a PET imaging procedure using 13N-ammonia, in a randomized sequence, within a 7-day interval.
13N-ammonia PET myocardial perfusion imagingDiagnostic test
Participants undergo myocardial perfusion imaging using 13N-ammonia with PET as the active comparator. This procedure is performed according to standard clinical protocols. Each participant also receives 99mTc-4BOH SPECT imaging in a randomized sequence, with both tests completed within a 7-day window.
| Study group | Role | What they receive |
|---|---|---|
| Cross-over Imaging with 99mTc-4BOH and 13N-ammonia | Experimental | Participants will undergo both 99mTc-4BOH SPECT and 13N-ammonia PET myocardial perfusion imaging in a randomized sequence, with the two imaging procedures performed within 7 days of each other. Coronary angiography and FFR measurement will be conducted within 30 days following both imaging sessions. Receives: Diagnostic Test: 99mTc-4BOH SPECT myocardial perfusion imaging; Diagnostic Test: 13N-ammonia PET myocardial perfusion imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 99mTc-4BOH SPECT myocardial perfusion imaging in detecting myocardial ischemia, compared to fractional flow reserve (FFR ≤0.80) as the diagnostic gold standard.
Measured: Within 30 days after both imaging procedures
Secondary outcomes (1)
Non-inferiority of 99mTc-4BOH SPECT vs. 13N-ammonia PET in detecting myocardial ischemia
Assessment of the non-inferiority of 99mTc-4BOH SPECT imaging compared to 13N-ammonia PET imaging in detecting myocardial ischemia, using FFR as the gold standard. Analysis will be based on paired comparison and pre-specified non-inferiority
Measured: Within 30 days after imaging and FFR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980194
- Sponsor's protocol ID
- 2024-GSP-TJ-2
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Center, Head-to-Head Clinical Trial Comparing 99mTc-4BOH SPECT Myocardial Perfusion Imaging With 13N-Ammonia PET Imaging for the Diagnosis of Myocardial Ischemia, Using Invasive Coronary Angiography and Fractional Flow Reserve as the Reference Standard
- ClinicalTrials.gov ID
- NCT06980194
- Acronym / sponsor ID
- 2024-GSP-TJ-2
- Conditions
- Coronary Artery Disease
- Keywords
- myocardial blood flow quantification, novel SPECT tracer, myocardial perfusion imaging
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 May 2025 (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.
The objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of 99mTc-4BOH SPECT myocardial perfusion imaging (MPI) compared to 13N-ammonia PET MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA).
Detailed description
The goal of this trial is to evaluate whether SPECT myocardial perfusion using the novel tracer 99mTc-4BOH is non-inferior to 13N-ammonia PET in diagnosing myocardial ischemia in patients with fractional flow reserve (FFR) as the diagnostic gold standard. In this study, 13N-ammonia PET imaging will be used as the positive control. Patients with diagnosed CAD who are scheduled for myocardial perfusion imaging will be assigned to undergo head-to-head SPECT imaging with 99mTc-4BOH and PET imaging with 13N-ammonia, with no more than 7 days between scans. All participants will subsequently undergo coronary angiography with FFR measurement within 30 days of imaging. The diagnostic performance of 99mTc-4BOH will be compared to that of 13N-ammonia, using FFR as the reference standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-over Imaging with 99mTc-4BOH and 13N-ammonia | Experimental | Diagnostic Test: 99mTc-4BOH SPECT myocardial perfusion imaging, Diagnostic Test: 13N-ammonia PET myocardial perfusion imagingParticipants will undergo both 99mTc-4BOH SPECT and 13N-ammonia PET myocardial perfusion imaging in a randomized sequence, with the two imaging procedures performed within 7 days of each other. Coronary angiography and FFR measurement will be conducted within 30 days following both imaging sessions. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 80 years. Presence of angina symptoms, such as chest tightness or chest pain. Coronary CT angiography (CTA) indicating ≥50% stenosis in at least one coronary artery.
- Able and willing to provide written informed consent.
Key exclusion criteria (3 listed)
- Underwent coronary revascularization (PCI or CABG) within the past 6 months. Presence of non-ischemic heart disease or left ventricular ejection fraction (LVEF) <35%.
- Contraindications to adenosine stress (e.g., bronchial asthma, second-degree or higher atrioventricular block, severe hypotension).
- Pregnancy or lactation. Unable or unwilling to sign the informed consent form.
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 |
|---|---|---|
| 99mTc-4BOH SPECT myocardial perfusion imagingParticipants undergo myocardial perfusion imaging using the investigational radiotracer 99mTc-4BOH with SPECT. Imaging is performed according to a standardized protocol. Each participant receives both this SPECT imaging and a PET imaging procedure using 13N-ammonia, in a randomized sequence, within a 7-day interval. | Diagnostic test | Cross-over Imaging with 99mTc-4BOH and 13N-ammonia |
| 13N-ammonia PET myocardial perfusion imagingParticipants undergo myocardial perfusion imaging using 13N-ammonia with PET as the active comparator. This procedure is performed according to standard clinical protocols. Each participant also receives 99mTc-4BOH SPECT imaging in a randomized sequence, with both tests completed within a 7-day window. | Diagnostic test | Cross-over Imaging with 99mTc-4BOH and 13N-ammonia |
Primary outcome
Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard
Time frame: Within 30 days after both imaging procedures
Diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) of 99mTc-4BOH SPECT myocardial perfusion imaging in detecting myocardial ischemia, compared to fractional flow reserve (FFR ≤0.80) as the diagnostic gold standard.
1 secondary outcome
Non-inferiority of 99mTc-4BOH SPECT vs. 13N-ammonia PET in detecting myocardial ischemia
Time frame: Within 30 days after imaging and FFR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 99mTc-4BOH SPECT myocardial perfusion imaging and 13N-ammonia PET myocardial perfusion imaging in people with Coronary Artery Disease, run by China National Center for Cardiovascular Diseases.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic accuracy of 99mTc-4BOH SPECT imaging for detecting myocardial ischemia, using FFR as the reference standard (time frame: Within 30 days after both imaging procedures). 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 20 May 2025.