Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Cognitive Function Clinical Trial

Official title:

Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05322824
• Other study ID #: ROSE
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: December 31, 2029

Study information

• Verified date: March 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD, MD
• Phone: 13958007213
• Email: lm99[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Cognitive Function
• Constriction, Pathologic
• Stenosis

Intervention

Drug:
• standard medical treatment
standard medical treatment

Procedure:
• Interventional stenting
Interventional stenting

Locations

Country	Name	City	State
China	Second Affilated Hospital of Zhejiang University, School of Medicine	HangZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the scores of Mini-mental State Examination	Total score of 30. Higher scores mean a better outcome.	2 years
Secondary	Incidence of stroke event including ischemic and hemorrhagic stroke		2 years
Secondary	Changes in cerebral glymphatic function	assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)	2 years
Secondary	Changes in the scores of Montreal Cognitive Assessment	Total score of 30	2 years
Secondary	Changes in cerebral blood flow in the territory of the culprit artery		2 years
Secondary	Changes in the scores of Colour Trail Test		2 years
Secondary	Changes in the scores of Hopkins Verbal Learning Test		2 years
Secondary	Changes in the scores of clock drawing test		2 years
Secondary	Changes in the scores of Animal Fluency Test		2 years
Secondary	Changes in the scores of Olfactory stick test		2 years
Secondary	Changes in metabonomics	include blood and fecal samples	2 years