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Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05322824
Enrollment
500
Registered
2022-04-12
Start date
2022-01-01
Completion date
2029-12-31
Last updated
2023-04-18

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

Conditions

Cognitive Function, Stenosis

Keywords

Cognitive Function, Intracranial / Carotid Stenosis

Brief summary

Through prospective registration and follow-up, this study will collect data of patients with intracranial/carotid stenosis, including clinical information, neuropsychological scales, multimodal magnetic resonance images. The investigators aim to analyze clinical and imaging characteristics of patients with cognitive impairment related to intracranial/carotid stenosis, in order to achieve early identification of cognitive impairment.

Interventions

DRUGstandard medical treatment

standard medical treatment

PROCEDUREInterventional stenting

Interventional stenting

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged ≥ 40 years * ≥ 50% stenosis in unilateral intracranial / carotid artery * Written informed consent available

Exclusion criteria

* Previous history of major head trauma and any intracranial surgery * Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions * Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement * Severe loss of vision, hearing, or communicative ability Exit Criteria: * Not meet the inclusion criteria * For any poor adherence, not comply with the requirements of the follow-up, or safety reasons determined by investigator * Any adverse or serious adverse events during the study period judged by investigator

Design outcomes

Primary

MeasureTime frameDescription
Changes in the scores of Mini-mental State Examination2 yearsTotal score of 30. Higher scores mean a better outcome.

Secondary

MeasureTime frameDescription
Changes in cerebral glymphatic function2 yearsassessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Changes in the scores of Montreal Cognitive Assessment2 yearsTotal score of 30
Changes in cerebral blood flow in the territory of the culprit artery2 years
Changes in the scores of Colour Trail Test2 years
Incidence of stroke event including ischemic and hemorrhagic stroke2 years
Changes in the scores of clock drawing test2 years
Changes in the scores of Animal Fluency Test2 years
Changes in the scores of Olfactory stick test2 years
Changes in metabonomics2 yearsinclude blood and fecal samples
Changes in the scores of Hopkins Verbal Learning Test2 years

Countries

China

Contacts

Primary ContactMin Lou, PhD, MD
lm99@zju.edu.cn13958007213

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026