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

N

Nanjing University of Traditional Chinese Medicine

Status

Not yet enrolling

Conditions

Carotid Artery Stenosis
Image

Treatments

Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image

Study type

Observational

Funder types

Other

Identifiers

NCT05848921
82071993-2

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

100 participants in 3 patient groups

CAS-CN
Description:
Carotid Artery Stenosis with cognitive normality
Treatment:
Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image
CAS-MCI
Description:
Carotid Artery Stenosis with mild cognitive impairment
Treatment:
Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image
HC
Description:
Healthy controls
Treatment:
Diagnostic Test: Neuropsychological scale
Device: magnetic resonance image

Trial contacts and locations

1

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Central trial contact

Lijun Bai, phD; Bo Yin, phD

Data sourced from clinicaltrials.gov

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