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Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study

A

Anhui Medical University

Status

Enrolling

Conditions

Intracranial Atherosclerosis
Cerebrovascular Event
Cognitive Impairment

Treatments

Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
Procedure: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Study type

Observational

Funder types

Other

Identifiers

NCT06336174
Anhui-SIA-cohort

Details and patient eligibility

About

The purpose of this study is to explore the mechanism of cognitive impairment in patients with symptomatic intracranial atherosclerotic stenosis (ICAS), and further plans to explore the impact of different treatment options on cognitive function in symptomatic ICAS patients.

Full description

All participants underwent a medical evaluation that included routine laboratory studies before and after 3-month and 1-year follow-up. Upon meeting the inclusion criteria and providing informed consent, each participant will complete a battery measure of neuropsychological tests, blood sample collection, and magnetic resonance imaging scan after enrollment and after 3-month and 1-year follow-up.

About 100 participants were included in this study. A series of neuropsychological tests were obtained by a trained investigator to assess. The tests include the evaluation of global cognitive function and multiple individual cognitive domains. The various tasks and questionnaires to measure cognition function including Montreal Cognitive Assessment (MoCA), Mini Mental State Examination (MMSE), Chinese Auditory Verbal Learning Test (CAVLT), Digital Span Test (DST), , Stroop color test (Stroop test), Color trail test (CTT), Clock Drawing Test (CDT), Verbal Fluency Test (VFT), etc., at the same time, the investigators also pay attention to the evaluation of participants' emotions by Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD). Furthermore, the memory and the occurrence of cerebrovascular events as the primary outcome measure, this study focused on the multidimensional cognitive function and cerebrovascular events of patients with symptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 3-month and 1-year follow-up, the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age between 18 and 80 years
  • Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
  • Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale [NIHSS] score ≤ 4 points)
  • Right-handed and able to cooperate in neuropsychological tests
  • At least 14 days post-onset of cerebral infarction or TIA
  • Signed informed consent

Exclusion criteria

  • Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
  • Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
  • More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
  • Vasculitis, moyamoya disease, and cardiogenic stroke
  • Previous history of head and neck stent implantation, carotid endarterectomy, aneurysm embolization, or other intracranial surgeries

Trial design

100 participants in 2 patient groups

Surgery Group
Description:
Symptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment
Treatment:
Procedure: Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
Medical group
Description:
Symptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy
Treatment:
Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Trial contacts and locations

1

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Central trial contact

Qiang Wei, PhD; Kai Wang, PhD

Data sourced from clinicaltrials.gov

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