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

NCT06336174 | Recruiting

• 1 other identifier: Anhui-SIA-cohort
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intracranial Atherosclerosis; Cognitive Impairment; Cerebrovascular Event

Keywords

Symptomatic Intracranial Atherosclerosis Stenosis; Cognitive Impairment; Cerebravascular Event

Outcome Measures

Primary Outcomes (2)

• The changes in Memory

  The changes in Memory function will constitute one of the main indicators of research results, which will be used to evaluate the follow-up results of the standard treatment regimen. The investigators will use the Chinese Auditory Verbal Learning Test (CAVLT) to evaluate the immediate, delayed and recognition memory of patients with symptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.

  baseline, 3-month and 1-year follow-up

• Occurrence of ischemic cerebrovascular events

  The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke.

  baseline, 3-month and 1-year follow-up

Secondary Outcomes (17)

• MoCA (Montreal Cognitive Assessment)

  baseline, 3-month and 1-year follow-up

• MMSE (Mini Mental State Examination)

  baseline, 3-month and 1-year follow-up

• DST (Digital Span Test; Forward and Backward)

  baseline, 3-month and 1-year follow-up

• The Stroop Color Test

  baseline, 3-month and 1-year follow-up

• CTT (Color Trail Test)

  baseline, 3-month and 1-year follow-up

Study Arms (2)

Surgery Group

Symptomatic intracranial stenosis patients who receive endovascular therapy combined with standard medical treatment

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

Medical group

Symptomatic intracranial stenosis patients who receive standard medical treatment without endovascular therapy

Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Interventions

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin DRUG

All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.

Medical group

Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin PROCEDURE

All patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.

Surgery Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with intracranial stenosis which was defined as stenosis of 70% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) with transient ischemic attack or minor stroke(NIHSS≤4 points).The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Anhui Medical University

Hefei, Anhui, 230032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum and anticoagulant

MeSH Terms

Conditions

Intracranial Arteriosclerosis; Cognitive Dysfunction

Interventions

Aspirin; Clopidogrel; Atorvastatin

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62922263; wangkai1964@126.com

Qiang Wei, PhD

CONTACT

+8618134516380; qiangwei_914@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology, Principal Investigator，Clinical Professor

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

CN (1)