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NCT Number: NCT05322824

Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

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.

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Key information

Conditions

Cognitive Function Arterial Occlusive Diseases Brain Diseases Cardiovascular Diseases Carotid Artery Diseases Carotid Stenosis Central Nervous System Diseases Cerebrovascular Disorders Constriction, Pathologic Nervous System Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Stenosis Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affilated Hospital of Zhejiang University, School of Medicine

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Min Lou, PhD, MD

CONTACT

[email protected]

13958007213

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Medical Treatment

Drug

standard medical treatment

Interventional stenting

Procedure

Interventional stenting

Primary outcomes

  1. Changes in the scores of Mini-mental State Examination

    Time frame: 2 years

    Total score of 30. Higher scores mean a better outcome.

Secondary outcomes

  1. Incidence of stroke event including ischemic and hemorrhagic stroke

    Time frame: 2 years

  2. Changes in cerebral glymphatic function

    Time frame: 2 years

    assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

  3. Changes in the scores of Montreal Cognitive Assessment

    Time frame: 2 years

    Total score of 30

  4. Changes in cerebral blood flow in the territory of the culprit artery

    Time frame: 2 years

  5. Changes in the scores of Colour Trail Test

    Time frame: 2 years

  6. Changes in the scores of Hopkins Verbal Learning Test

    Time frame: 2 years

  7. Changes in the scores of clock drawing test

    Time frame: 2 years

  8. Changes in the scores of Animal Fluency Test

    Time frame: 2 years

  9. Changes in the scores of Olfactory stick test

    Time frame: 2 years

  10. Changes in metabonomics

    Time frame: 2 years

    include blood and fecal samples

Study contacts

Contact information is provided by the study sponsor or research team.

Min Lou, PhD, MD

CONTACT

[email protected]

13958007213

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Apr 12, 2022
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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