Assess the Risk of Cerebrovascular Disease

NCT ID: NCT04443439

Last Updated: 2022-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-09

Study Completion Date

2026-12-01

Brief Summary

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Intracranial artery stenosis is an important cause of ischemic stroke, but the degree of intracranial artery stenosis is not completely matched with the symptoms of ischemic stroke. Asymptomatic carotid stenosis (ACS) refers to does not appear related neurological symptoms of carotid stenosis and stroke or transient ischemic attack of carotid stenosis, did not happen cerebrovascular events such as stroke, but there have been a different degree of cognitive impairment, be badly in need of development of noninvasive imaging methods, objective evaluation of the ACS group cognitive impairment, and predict the ACS risk of ischemic stroke. Therefore, this topic proposed comprehensive cognitive assessment, CTA, double modal MRI techniques, clinical and biochemical indicator detection, mathematical modeling and statistical analysis techniques, assess the ACS group and normal person the cognitive ability, the difference of NVC and local perfusion, and follow-up ACS crowd of ischemic stroke and other cardiovascular events, discuss ACS and cognitive impairment, the correlation of NVC and local perfusion abnormalities, screening of radiographic predictor of ischemic stroke, and in the follow-up of ACS population in testing the sensitivity of the series of indicators and specific degrees.

Detailed Description

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Conditions

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Cerebrovascular Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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No related neurological symptoms and transient ischemic attack

Mild stenosis group: CTA suggested carotid stenosis \< 30%; Moderate stenosis group: CTA suggested carotid stenosis of 30-69%; Severe stenosis group: CTA indicated carotid stenosis ≥70%;

GE Discovery MR750 3.0t superconducting MRI

Intervention Type DEVICE

T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions

Interventions

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GE Discovery MR750 3.0t superconducting MRI

T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Mild stenosis group: CTA suggested carotid stenosis \< 30%;
2. Moderate stenosis group: CTA suggested carotid stenosis of 30-69%;
3. Severe stenosis group: CTA indicated carotid stenosis ≥70%;

Exclusion Criteria

1. dementia, MMSE score \< 21;
2. previous carotid stenosis related neurological symptoms or transient ischemic attack;
3. other craniocerebral lesions, such as craniocerebral trauma, tumor, inflammation, and complications of great vessels (cerebral infarction or cerebral malacia);
4. contraindications for MRI examination;
5. recent use of psychoactive drugs or hormones.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Wen Wang, MD & PhD

Director of radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wen Wang

Xi'an, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Wen Wang, Ph.D.

Role: CONTACT

+8618629066628 ext. +8618629066628

Facility Contacts

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Wen Wang, Ph.D.

Role: primary

+8618629066628 ext. +8618629066628

Provided Documents

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Document Type: Study Protocol: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2018LCYJ005

Identifier Type: -

Identifier Source: org_study_id

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