Assess the Risk of Cerebrovascular Disease

October 23, 2022 updated by: Wen Wang, MD & PhD, Tang-Du Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Xi'an, China, 710038
        • Recruiting
        • Wen Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
2020.01

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tang-Du Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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