Evaluation of Brain Health and Surgical Efficacy in Patients With Carotid Artery Stenosis

NCT ID: NCT05848921

Last Updated: 2023-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2025-12-31

Brief Summary

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The purpose of this study is to explore the relationship between the recovery of cerebrovascular morphology and cognitive function before and after surgical treatment in patients with carotid artery stenosis and their preoperative cardiac health status. And combined with preoperative cognitive status, serum markers, and cardiovascular health evaluation indicators, evaluate and predict the possibility of postoperative neurodegenerative diseases and the level of cerebrovascular health in patients.

Detailed Description

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The aim of this study is to evaluate the brain health status and surgical efficacy of patients with carotid artery stenosis. Firstly, investigate whether hemodynamic parameters such as blood flow reserve fraction at the carotid artery stenosis site are correlated with white matter hyperintensities and cerebral vascular morphological changes in elderly patients with normal cognition and mild cognitive impairment; Then, when the blood flow of carotid artery has been improved after surgery, compare the cerebrovascular health of patients before surgery and the way of cerebral vascular reconstruction; Combined with the postoperative neuropsychological cognitive test to explore the postoperative cognitive recovery of patients, and combined with the postoperative imaging data and the biomarker in the blood of patients at various stages, to explore the way of cerebral vascular reconstruction and changes in brain structure and function of different groups of patients behind cognitive changes.

Conditions

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Carotid Artery Stenosis Image

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CAS-CN

Carotid Artery Stenosis with cognitive normality

magnetic resonance image

Intervention Type DEVICE

Imaging data were collected in a strong magnetic field

Neuropsychological scale

Intervention Type DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

CAS-MCI

Carotid Artery Stenosis with mild cognitive impairment

magnetic resonance image

Intervention Type DEVICE

Imaging data were collected in a strong magnetic field

Neuropsychological scale

Intervention Type DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

HC

Healthy controls

magnetic resonance image

Intervention Type DEVICE

Imaging data were collected in a strong magnetic field

Neuropsychological scale

Intervention Type DIAGNOSTIC_TEST

Multi dimensional neuropsychological test

Interventions

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magnetic resonance image

Imaging data were collected in a strong magnetic field

Intervention Type DEVICE

Neuropsychological scale

Multi dimensional neuropsychological test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged over 50 years old;
* Conscious and capable of completing neuropsychological scales
* Clinical detection of carotid artery stenosis requires surgical treatment;
* Compliant with carotid artery stenting or carotid endarterectomy surgical standards
* Individuals with normal cognition and mild cognitive impairment

Exclusion Criteria

* Degree of vascular blockage in other intracranial segments ≥ 50%
* Have a history of mental illness, nervous system disease (such as stroke) or brain injury with loss of consciousness for more than five minutes;
* Neurological and psychiatric disorders unrelated to AD (schizophrenia, depression, etc.), post-traumatic stress disorder, obsessive-compulsive disorder, multiple sclerosis, amyotrophic lateral sclerosis)
* Have a history of alcohol or drug abuse
* There are contraindications for magnetic resonance imaging examination
* Those with significant organ dysfunction such as lung, liver, and kidney;
* Patients with intracranial tumors, infectious diseases, and blood system diseases;
* Participating in other clinical studies at the same time
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

The 2rd School of Medicine,WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU

UNKNOWN

Sponsor Role collaborator

Nanjing University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Qianyan Liu

Principal Investgator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Yin, phD

Role: PRINCIPAL_INVESTIGATOR

The 2rd School of Medicine,WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU

Locations

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The 2rd School of Medicine,WMU/The 2rd Affiliated Hospital and Yuying Children's Hospiyal of WMU

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Central Contacts

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Bo Yin, phD

Role: CONTACT

0086-13857773745

Lijun Bai, phD

Role: CONTACT

0086-15129034948

Facility Contacts

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Bo Yin, phD

Role: primary

0086-13857773745

Lijun Bai, phD

Role: backup

0086-15129034948

Other Identifiers

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82071993-2

Identifier Type: -

Identifier Source: org_study_id

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