Clinical Registration Study of Patients With Intracranial... | NCT05322824

Studies
Clinical Registration Study of Patients With Intracranial / Carotid Stenosis

NCT05322824

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Recruiting

Last Update Posted

Apr 18, 2023Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Cognitive Function
Stenosis

Interventions

standard medical treatment
Interventional stenting

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2029Estimated

First Submitted Date

Apr 1, 2022

First Submission Date that Met QC Criteria

Apr 10, 2022

First Posted Date

Apr 12, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2023

Last Update Posted Date

Apr 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standard medical treatment	Drug	standard medical treatment
Interventional stenting	Procedure	Interventional stenting

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in the scores of Mini-mental State Examination	Total score of 30. Higher scores mean a better outcome.	2 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of stroke event including ischemic and hemorrhagic stroke		2 years
Changes in cerebral glymphatic function	assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with intracranial / carotid stenosis aged ≥ 40 years

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Min Lou, PhD, MD	Contact	13958007213		lm99@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Second Affilated Hospital of Zhejiang University, School of Medicine	Recruiting	Hangzhou	Zhejiang	310009	China

Condition Browse Module

MeSH Terms

ID	Term
D003251	Constriction, Pathologic
D016893	Carotid Stenosis

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided