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NCT06280287 Clinical Trial

PET Imaging of Fibroblast Activation in Atherosclerosis

Atherosclerosis Clinical Trial

Official title:
PET Imaging of Fibroblast Activation in Carotid and Coronary Atherosclerotic Disease

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06280287
Other study ID # FAPI-PLAQUE
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 1, 2021
Est. completion date December 31, 2025

Study information
Verified date February 2024
Source Peking Union Medical College Hospital
Contact Li Huo
Phone +861069155513
Email huoli@pumch.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FAPI 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

Locations
Country Name City State
China Peking Union Medical College Hospital Beijing Beijing

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary SUVmax of atherosclerotic plaque in carotid or coronary arteries through study completion, an average of 2 years
Primary TBR of atherosclerotic plaque in carotid or coronary arteries through study completion, an average of 2 years
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