Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05322824

Collaborator

(none)

500

Enrollment

Location

Anticipated Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cognitive Function Stenosis	Drug: standard medical treatment Procedure: Interventional stenting

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2027

Anticipated Study Completion Date :

Dec 31, 2029

Outcome Measures

Primary Outcome Measures

Changes in the scores of Mini-mental State Examination [2 years]
Total score of 30. Higher scores mean a better outcome.

Secondary Outcome Measures

Incidence of stroke event including ischemic and hemorrhagic stroke [2 years]
Changes in cerebral glymphatic function [2 years]
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Changes in the scores of Montreal Cognitive Assessment [2 years]
Total score of 30
Changes in cerebral blood flow in the territory of the culprit artery [2 years]
Changes in the scores of Colour Trail Test [2 years]
Changes in the scores of Hopkins Verbal Learning Test [2 years]
Changes in the scores of clock drawing test [2 years]
Changes in the scores of Animal Fluency Test [2 years]
Changes in the scores of Olfactory stick test [2 years]
Changes in metabonomics [2 years]
include blood and fecal samples

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affilated Hospital of Zhejiang University, School of Medicine	HangZhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05322824

Other Study ID Numbers:

ROSE

First Posted:

Apr 12, 2022

Last Update Posted:

Apr 12, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Second Affiliated Hospital, School of Medicine, Zhejiang University

Cognitive Function

Intracranial / Carotid Stenosis

Additional relevant MeSH terms:

Carotid Stenosis

Constriction, Pathologic

Study Results

No Results Posted as of Apr 12, 2022