PET Imaging of Fibroblast Activation in Atherosclerosis

Recruiting

• Conditions: Atherosclerosis

• 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

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