PET Imaging of Fibroblast Activation in Atherosclerosis

NCT ID: NCT06280287

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Atherosclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Carotid stenosis

Patients with carotid stenosis and suitable for carotid endarterectomy

FAPI PET

Intervention Type DIAGNOSTIC_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

Coronary artery disease

Patients with stable ischemic heart disease or acute coronary syndrome

FAPI PET

Intervention Type DIAGNOSTIC_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

Interventions

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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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Li Huo

Role: CONTACT

+861069155513

Facility Contacts

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Li Huo

Role: primary

86-13910801986

Other Identifiers

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FAPI-PLAQUE

Identifier Type: -

Identifier Source: org_study_id

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