Assess the Risk of Cerebrovascular Disease

Head and Neck CTA Combined With Multimodal MRI to Assess the Risk of Cerebrovascular Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebrovascular Disease
• Intervention / Treatment: Device: GE Discovery MR750 3.0t superconducting MRI

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Wen Wang, Ph.D.; Phone Number: +8618629066628 +8618629066628; Email: wangwen@fmmu.edu.cn

Study Locations

• China
  • Xi'an, China, 710038
    • Recruiting
    • Wen Wang
    • Contact: Wen Wang, Ph.D.; Phone Number: +8618629066628 +8618629066628; Email: wangwen@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Anticipated): November 15, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: May 27, 2020
• First Submitted That Met QC Criteria: June 21, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 23, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders
• Other Study ID Numbers: 2018LCYJ005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No