Assess the Risk of Cerebrovascular Disease

Sponsor

Tang-Du Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04443439

Collaborator

(none)

100

Enrollment

Location

1.7

Actual Duration (Months)

57.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebrovascular Disease	Device: GE Discovery MR750 3.0t superconducting MRI

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 9, 2020

Actual Primary Completion Date :

Nov 15, 2020

Actual Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Dynamic change and correlation analysis of multi-dimensional features of ACS degree and cognitive impairment [2020.01]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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%;

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wen Wang	Xi'an		China	710038

Sponsors and Collaborators

Tang-Du Hospital

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.

Responsible Party:

wangwen, Director of radiology, Tang-Du Hospital

ClinicalTrials.gov Identifier:

NCT04443439

Other Study ID Numbers:

2018LCYJ005

First Posted:

Jun 23, 2020

Last Update Posted:

May 10, 2021

Last Verified:

May 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cerebrovascular Disorders

Study Results

No Results Posted as of May 10, 2021