About this trial
Carotid atherosclerotic plaque rupture is the main cause of ischemic stroke attacks, and early and precise assessment of plaque vulnerability can prevent ischemic stroke. High-resolution MRI can reflect vulnerable plaque features such as thin fibrous caps and large lipid cores, but cannot assess their metabolic information; Fibro-activated proteins (FAPs) of PET are specifically expressed in atherosclerosis and suggest vulnerable plaques by reflecting inflammation-induced fibrosis. The aim of this study was to apply 18F FDG\&68Ga-FAPI PET/MR imaging to investigate the vulnerability of carotid atherosclerotic plaques, to obtain quantitative evaluation indexes of active fibrosis within carotid plaques, and to clarify the PET/MR characteristics of unstable plaques in carotid arteries
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
Absolute or relative contraindications related to PET/MR imaging safety (e.g., metallic implants, MRI phobia, etc.); Patients who have undergone carotid endarterectomy (CEA) or carotid artery stenting (CAS); Pregnant or lactating women; Presence of other vascular diseases, such as vasculitis, moyamoya disease, arterial dissection, etc.; Severe agitation or inability to cooperate with imaging procedures.
Trial population
The study included a total of 100 patients with internal carotid artery atherosclerosis, divided into 50 cases in the symptomatic group and 50 cases in the asymptomatic group.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
stroke from baseline to 1months after PET/MR
1\. Incidence of ipsilateral carotid cerebral infarction Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy
stroke from baseline to 6 months after PET/MR
1\. Incidence of ipsilateral carotid cerebral infarction Incidence within 6 month of standard drug therapy or carotid stenting or carotid endarterectomy
stroke from baseline to 12 months after PET/MR
1\. Incidence of ipsilateral carotid cerebral infarction Incidence within 12 month of standard drug therapy or carotid stenting or carotid endarterectomy
cerebral hemorrhage from baseline to 1months after PET/MR
1\. Incidence of ipsilateral carotid cerebral hemorrhage Incidence within 1 month of standard drug therapy or carotid stenting or carotid endarterectomy
Secondary outcomes
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 1 months after PET/MRI
1\. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 1 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 6 months after PET/MRI
1\. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 6 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed
18F FDG and 68Ga FAPI PET-MRI imaging results from baseline to 12 months after PET/MRI
1\. Changes in metabolic rate of ipsilateral carotid plaque Changes in metabolic rate of 18F FDG and 68Ga FAPI within 12 month after standard drug therapy or carotid stenting or carotid endarterectomy were observed
Sponsors and contacts
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Ruijin Hospital
Lead sponsor
National Natural Science Foundation of China
Collaborator