Assess the Risk of Cerebrovascular Disease

NCT04443439 | Recruiting

• 1 other identifier: 2018LCYJ005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cerebrovascular Disease

Outcome Measures

Primary Outcomes (1)

• Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment

  The Montreal cognitive assessment (MoCA) scale was used to evaluate the differences in cognitive function between ACS and the healthy control group in different dimensions, and the horizontal correlation analysis between ACS and cognitive impairment was conducted according to the dimensions of cognitive impairment and the degree of ACS.

  2020.01

Study Arms (1)

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%;

Device: GE Discovery MR750 3.0t superconducting MRI

Interventions

GE Discovery MR750 3.0t superconducting MRI DEVICE

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

No related neurological symptoms and transient ischemic attack

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

No carotid stenosis - related neurological symptoms and transient ischemic attacks (50 patients in each group, 25 males and 25 females).

You may qualify if:

• 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%;

You may not qualify if:

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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Wen Wang

Xi'an, 710038, China

RECRUITING

MeSH Terms

Conditions

Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Wen Wang, Ph.D.

CONTACT

+8618629066628; wangwen@fmmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of radiology

Study Record Dates

• First Submitted: May 27, 2020
• First Posted: June 23, 2020
• Study Start: October 9, 2020
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 25, 2022

Record last verified: 2022-10

Locations

CN (1)