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Application research of Sigma imaging agent FBFP in Ischemic stroke

Application research of Sigma imaging agent FBFP in Ischemic stroke

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112513
Enrollment
Unknown
Registered
2025-11-14
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke

Interventions

Healthy control group:NA
Unilateral internal carotid artery stenosis group:NA

Sponsors

Xuanwu Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Angiography diagnosis shows unilateral anterior circulation head and neck artery stenosis with a diameter reduction of>70%, and there is no stenosis in the contralateral anterior circulation or bilateral posterior circulation with a diameter reduction of>50%; 2. Transient ischemic attack or ischemic stroke that must have occurred within the past 12 months in the affected vascular area, with the most recent attack lasting more than 3 weeks; 3. MRI shows no new intracranial infarction lesions; 4. No previous infarction lesions in the pontine area; 5. Either PET/MR blood flow or metabolic imaging shows reduced blood flow and metabolism in the affected hemisphere, with a reduction rate exceeding 10% compared to the contralateral region; 6. Subjects and informants can complete relevant examinations and follow-up work; 7. The subject or their authorized representative signs the informed consent form; 8. Control group: 20 normal healthy individuals recruited from the rehabilitation department outpatient clinic, matched with the patient group in terms of gender and age. Exclusion criteria: no history of cerebral ischemia or other related diseases.

Exclusion criteria

Exclusion criteria: 1. Poor image quality due to head movement and other reasons during the scanning process; 2. There are other neurological disorders that can cause brain dysfunction, such as depression, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, normal intracranial pressure hydrocephalus, etc; 3. There are other systemic diseases that can cause cognitive impairment, such as liver dysfunction, kidney dysfunction, thyroid dysfunction, severe anemia, folate and vitamin B12 deficiency, special infections (such as syphilis, HIV), alcohol and drug abuse, etc; 4. Existence of mental and neurological developmental delay; 5. There are other known diseases that may cause cognitive impairment; 6. Individuals with severe visual and hearing impairments, claustrophobia, and other conditions who cannot cooperate with MRI examinations; 7. Suffering from diseases that prevent cooperation in completing cognitive examinations; 8. Refusal to sign informed consent form during baseline period;

Design outcomes

Primary

MeasureTime frame
Standardized Uptake Value;

Secondary

MeasureTime frame
National Institutes of Health Stroke Scale;modified Rankin Scale;

Countries

China

Contacts

Public ContactJie Lu

Xuanwu Hospital, Capital Medical University

imaginglu@hotmail.com+86 10 8319 8379

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026