Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients: A Cohort Study
Overview
- Phase
- N/A
- Intervention
- Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
- Conditions
- Asymptomatic Intracranial Stenosis
- Sponsor
- Anhui Medical University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Occurrence of ischemic cerebrovascular events
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
WANG KAI
Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab Anhui Medical University, PRC
Anhui Medical University
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
Patient Group
Asymptomatic intracranial stenosis patients who receive standard medical treatment without stenting
Intervention: Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
Outcomes
Primary Outcomes
Occurrence of ischemic cerebrovascular events
Time Frame: baseline, 1 and 2 years after follow-up
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.
The changes in Memory
Time Frame: baseline, 1 and 2 years after follow-up
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.
Secondary Outcomes
- MMSE (Mini Mental State Examination)(baseline, 1 and 2 years after follow-up)
- MoCA (Montreal Cognitive Assessment)(baseline, 1 and 2 years after follow-up)
- HAMA (Hamilton Anxiety Scale)(baseline, 1 and 2 years after follow-up)
- Ultrasound measures-IMT( intima-media thickness)(baseline, 1 and 2 years after follow-up)
- DST (Digital Span Test; Forward and Backward)(baseline, 1 and 2 years after follow-up)
- CTT (Color Trail Test)(baseline, 1 and 2 years after follow-up)
- JoLO (Judgment of Line Orientation)(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)
- ROCF (Rey-Osterrieth Complex Figure)(baseline, 1 and 2 years after follow-up)
- VFT (Verbal Fluency Test)(baseline, 1 and 2 years after follow-up)
- BNT (Boston Naming Test)(baseline, 1 and 2 years after follow-up)
- LANT (Lateralized attention network test)(baseline, 1 and 2 years after follow-up)
- Ultrasound measures-MCA-PI(middle cerebral artery-pulsatility index)(baseline, 1 and 2 years after follow-up)
- Blood Metabolomics measures-CRP(C-reactive protiein)(baseline, 1 and 2 years after follow-up)
- Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)(baseline, 1 and 2 years after follow-up)
- Blood Metabolomics measures-miRNA（microRNA）(baseline, 1 and 2 years after follow-up)
- HAMD (Hamilton Depression Scale)(baseline, 1 and 2 years after follow-up)
- MRI measure- resting state MRI images(baseline, 1 and 2 years after follow-up)
- MRI measures-structural phase MRI images(baseline, 1 and 2 years after follow-up)
- MRI measures-3D pCASL images(baseline, 1 and 2 years after follow-up)
- Ultrasound measures-BHI(breath-holding index)(baseline, 1 and 2 years after follow-up)