Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients

NCT ID: NCT05504330

Last Updated: 2024-04-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2025-12-31

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.

Detailed Description

All participants underwent a medical evaluation that included routine laboratory studies before and after 1- and 2-years 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 1- and 2-years 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), Symbol digital modalities test(SDMT), Stroop color test(Stroop test), Color trail test(CTT), Rey-Osterrieth Complex Figure(ROCF), Judgment of Line Orientation (JoLO), Verbal Fluency Test(VFT), Boston Naming Test (BNT) , Lateralized attention network test(LANT) 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 as the primary outcome measure, this study focused on the immediate memory, delayed memory and recognition memory of patients with asymptomatic ICAS. Blood sample will be collected for biological multiomics research. The patients will receive a magnetic resonance imaging scan in multi-modalities.

After 1 and 2 years follow-up,the participants will be interviewed to obtain the same assessments, blood sample and magnetic resonance imaging scan in multi-modalities as before.

Conditions

Asymptomatic Intracranial Stenosis; Cognitive Impairment; Cerebrovascular Event

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient Group

Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

Intervention Type: 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.

Healthy Control

Healthy control are free from intracranial stenosis

No interventions assigned to this group

Interventions

Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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).

2. The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).

Exclusion Criteria

1. History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.

2. Organic brain defects on MRI T1 or T2 images.

3. Any history or clinical signs of other severe psychiatric illnesses (like major depression,psychosis or obsessive compulsive disorder).

4. Implanted pacemaker,medication pump,vagal stimulator,deep brain stimulator. History of substance abuse within the last 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Medical University

OTHER

Sponsor Role: lead

Responsible Party

WANG KAI

Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab Anhui Medical University, PRC

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anhui Medical University

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Kai Wang, PhD

Role: CONTACT

wangkai1964@126.com

+86-0551-62922263

Qiang Wei, PhD

Role: CONTACT

qiangwei_914@126.com

+86-62922418

Facility Contacts

Qiang Wei, PhD

Role: primary

qiangwei_914@126.com

+86-62922418

Other Identifiers

Anhui-AsIA-cohort

Identifier Type: -

Identifier Source: org_study_id