PET Imaging of Fibroblast Activation in Atherosclerosis

Recruiting

• Conditions: Atherosclerosis
• Interventions: Diagnostic Test: FAPI PET

• Registration Number: NCT06280287
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2024-01-17
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-25
• Last Update Submitted: 2024-02-25
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Carotid stenosis	FAPI PET	Patients with carotid stenosis and suitable for carotid endarterectomy
Coronary artery disease	FAPI PET	Patients with stable ischemic heart disease or acute coronary syndrome

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China