Assess the Risk of Cerebrovascular Disease

Cerebrovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443439
• Other study ID #: 2018LCYJ005
• Status: Recruiting
• Start date: October 9, 2020
• Est. completion date: December 1, 2026

Study information

• Verified date: October 2022
• Source: Tang-Du Hospital
• Contact: Wen Wang, Ph.D.
• Phone: +8618629066628
• Email: wangwen[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: November 15, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrovascular Disease
• Cerebrovascular Disorders

Intervention

Device:
• GE Discovery MR750 3.0t superconducting MRI
T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions

Locations

Country	Name	City	State
China	Wen Wang	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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