AtherosclerosisNCT06280287
PET Imaging of Fibroblast Activation in Atherosclerosis
An observational study of Atherosclerosis, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Atherosclerosis
- What is being tested?
- FAPI PET
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with carotid stenosis or CAD.
Who may be able to join
- For the carotid stenosis group: patients with symptomatic carotid stenosis with >50% stenosis on carotid CTA; OR patients with unsymptomatic carotid stenosis with >70% stenosis on carotid CTA
- For CAD group: patients with stable ischemic heart disease OR acute coronary syndrome, including ST-elevation MId, non-ST elevation MI, and unstable angina
- signed informed consent
Who cannot join
- Pregnancy, lactation, or intention to become pregnant during the study
- Contradiction to MRI or CTA
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Li Huo, 86-13910801986, huoli@pumch.cn
About this study
Official title: PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease
Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.
Read the detailed description
Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis. Abundant FAP-expressing cells in atherosclerotic plaques co-express endothelial biomarkers involved in endothelial-to-mesenchymal transition. FAP upregulation is also associated with a rupture-prone plaque phenotype with a thin fibrous cap. Positron emission tomography (PET) with 68Ga-FAPI-04 has been demonstrated as a feasible method to image fibroblastic activation in the arterial wall. The current study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.
- Conditions
- Atherosclerosis
- Being tested
- FAPI PET
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PETDiagnostic test
68Ga-FAPI PET/MR with high-resolution cardiovascular magnetic resonance vessel wall imaging for patients with carotid stenosis; 18FAl-FAPI PET/CT for patients with coronary artery disease
| Study group | Role | What they receive |
|---|---|---|
| Carotid stenosis | Patients with carotid stenosis and suitable for carotid endarterectomy Receives: Diagnostic Test: FAPI PET | |
| Coronary artery disease | Patients with stable ischemic heart disease or acute coronary syndrome Receives: Diagnostic Test: FAPI PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUVmax of atherosclerotic plaque in carotid or coronary arteries
Measured: through study completion, an average of 2 years
TBR of atherosclerotic plaque in carotid or coronary arteries
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280287
- Sponsor's protocol ID
- FAPI-PLAQUE
- Status last verified
- Feb 2024
- First submitted
- 17 Jan 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shi X, Wang L, Zhang H, Wu M, Ren C, Xue S, Huang Z, Hao Z, Lai Z, Liu B, Hacker M, Liu Z, Li X, Huo L. FAPI PET/CT in post-PCI coronary disease: in-stent restenosis characterization, MACE association, and limited short-term modulation by lipid-lowering therapy: FAPI athero trial. Eur J Nucl Med Mol Imaging. 2026 Aug;53(10):6050-6062. doi: 10.1007/s00259-026-07970-8. Epub 2026 Jun 3.
PubMed 42234008
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease
- ClinicalTrials.gov ID
- NCT06280287
- Acronym / sponsor ID
- FAPI-PLAQUE
- Conditions
- Atherosclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Feb 2024 (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.
Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis, associated with endothelial-to-mesenchymal transition and a rupture-prone plaque phenotype. This study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.
Detailed description
Fibroblast activation protein (FAP) is a fibroblast-specific marker expressed in atherosclerosis. Abundant FAP-expressing cells in atherosclerotic plaques co-express endothelial biomarkers involved in endothelial-to-mesenchymal transition. FAP upregulation is also associated with a rupture-prone plaque phenotype with a thin fibrous cap. Positron emission tomography (PET) with 68Ga-FAPI-04 has been demonstrated as a feasible method to image fibroblastic activation in the arterial wall. The current study aims to evaluate in-vivo fibroblast activation in carotid and coronary atherosclerotic diseases with FAPI PET and its correlation with histological vulnerability and clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carotid stenosis | – | Diagnostic Test: FAPI PETPatients with carotid stenosis and suitable for carotid endarterectomy |
| Coronary artery disease | – | Diagnostic Test: FAPI PETPatients with stable ischemic heart disease or acute coronary syndrome |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid stenosis or CAD.
Key inclusion criteria (3 listed)
- For the carotid stenosis group: patients with symptomatic carotid stenosis with >50% stenosis on carotid CTA; OR patients with unsymptomatic carotid stenosis with >70% stenosis on carotid CTA
- For CAD group: patients with stable ischemic heart disease OR acute coronary syndrome, including ST-elevation MId, non-ST elevation MI, and unstable angina
- signed informed consent
Key exclusion criteria (2 listed)
- Pregnancy, lactation, or intention to become pregnant during the study
- Contradiction to MRI or CTA
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 |
|---|---|---|
| FAPI PET68Ga-FAPI PET/MR with high-resolution cardiovascular magnetic resonance vessel wall imaging for patients with carotid stenosis; 18FAl-FAPI PET/CT for patients with coronary artery disease | Diagnostic test | Carotid stenosis, Coronary artery disease |
Primary outcome
SUVmax of atherosclerotic plaque in carotid or coronary arteries
Time frame: through study completion, an average of 2 years
TBR of atherosclerotic plaque in carotid or coronary arteries
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 42234008Shi X, Wang L, Zhang H, Wu M, Ren C, Xue S, Huang Z, Hao Z, Lai Z, Liu B, Hacker M, Liu Z, Li X, Huo L. FAPI PET/CT in post-PCI coronary disease: in-stent restenosis characterization, MACE association, and limited short-term modulation by lipid-lowering therapy: FAPI athero trial. Eur J Nucl Med Mol Imaging. 2026 Aug;53(10):6050-6062. doi: 10.1007/s00259-026-07970-8. Epub 2026 Jun 3.
- Individual participant dataSharing planned: Undecided
Related trials for Atherosclerosis
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
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.
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 Atherosclerosis, run by Peking Union Medical College Hospital 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Huo (+861069155513, huoli@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUVmax of atherosclerotic plaque in carotid or coronary arteries (time frame: through study completion, an average of 2 years). 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?
On the ClinicalTrials.gov record for NCT06280287, which also lists 1 linked publication.
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 28 Feb 2024.