PET Imaging of Fibroblast Activation in Atherosclerosis

NCT06280287 | Recruiting

• 1 other identifier: FAPI-PLAQUE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Carotid stenosis

Patients with carotid stenosis and suitable for carotid endarterectomy

Diagnostic Test: FAPI PET

Coronary artery disease

Patients with stable ischemic heart disease or acute coronary syndrome

Diagnostic Test: FAPI PET

Interventions

FAPI PET 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

Carotid stenosis; Coronary artery disease

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with carotid stenosis or CAD.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Li Huo

CONTACT

+861069155513; huoli@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 28, 2024
• Study Start: August 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Locations

CN (1)