Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients

NCT05504330 | Recruiting

• 1 other identifier: Anhui-AsIA-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 asymptomatic intracranial atherosclerotic stenosis(ICAS),and to examine the natural history and the pathogenesis of asymptomatic ICAS.

Conditions

Asymptomatic Intracranial Stenosis; Cognitive Impairment; Cerebrovascular Event

Keywords

Asymptomatic Intracranial Stenosis patients; Cognitive Impairment; Cerebrovascular 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 asymptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.

  baseline, 1 and 2 years after 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 vascular 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, 1 and 2 years after follow-up

Secondary Outcomes (22)

• MoCA (Montreal Cognitive Assessment)

  baseline, 1 and 2 years after follow-up

• MMSE (Mini Mental State Examination)

  baseline, 1 and 2 years after follow-up

• DST (Digital Span Test; Forward and Backward)

  baseline, 1 and 2 years after follow-up

• SDMT (Symbol digital modalities test)

  baseline, 1 and 2 years after follow-up

• The Stroop color test

  baseline, 1 and 2 years after follow-up

Study Arms (2)

Patient Group

Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting

Drug: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Healthy Control

Healthy control are free from intracranial stenosis

Interventions

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin DRUG

First of all, ICAS patients were given health education to exhort them to reduce the risk factors of exposure to stroke and get rid of their unhealthy lifestyles. Secondly, for patients in need, standardize their dosage and course of treatment, mainly including antiplatelet drugs and statins. In addition, patients with diabetes and hypertension urge rational medication to control blood pressure and blood glucose level.

Patient 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 50% or more in Intracranial segment of internal carotid artery and middle cerebral artery (MCA) without history of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.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:

• Patients with intracranial stenosis which was defined as stenosis of 50% or more in Intracranial segment of internal carotid artery(C6-C7) and middle cerebral artery (M1).
• The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

You may not qualify if:

• History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
• Organic brain defects on MRI T1 or T2 images.
• Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).
• Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.

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

Cognitive Dysfunction

Interventions

Aspirin; Clopidogrel; Atorvastatin

Condition Hierarchy (Ancestors)

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

+86-62922418; qiangwei_914@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab Anhui Medical University, PRC

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: August 17, 2022
• Study Start: August 15, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Locations

CN (1)