PET Imaging of Fibroblast Activation in Atherosclerosis

PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06280287

Enrollment

150

Registered

2024-02-28

Start date

2021-08-01

Completion date

2025-12-31

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

Brief 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. 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.

Interventions

DIAGNOSTIC_TESTFAPI PET

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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* Pregnancy, lactation, or intention to become pregnant during the study * Contradiction to MRI or CTA

Design outcomes

Primary

Measure	Time frame
SUVmax of atherosclerotic plaque in carotid or coronary arteries	through study completion, an average of 2 years
TBR of atherosclerotic plaque in carotid or coronary arteries	through study completion, an average of 2 years

Countries

China

Contacts

Primary ContactLi Huo

huoli@pumch.cn+861069155513

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026