Clinical trial NCT06336174: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study
Official title: Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Atherosclerotic Stenosis Patients: A Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Atherosclerosis
Cognitive Impairment
Cerebrovascular Event
Keywords: Symptomatic Intracranial Atherosclerosis Stenosis
Cognitive Impairment
Cerebravascular Event
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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) 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).

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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. Non-illiterates, no symptoms and signs of central nervous system dysfunction, head CT or head MRI showed normal cerebral parenchyma or old lacunar cerebral infarction, and non-thalamus, frontal lobe, temporal lobe and other cognitively related infarction;
2. TCD\\CTA\\MRA\\DSA present intracranial artery stenosis (50% or more) or occlusion;
3. History of vascular-related TIA and acute cerebral infarction (more than 2 weeks after lastest), and NIHSS score was less than or equivalent to 4 points at the time of enrollment;

Exclusion Criteria:

1. History of stroke,transient ischemic attack,seizures or unexplained loss of consciousness.
2. Organic brain defects on 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

Primary outcomes:
measure: The changes in Memory
timeFrame: baseline, 3-month and 1-year follow-up
measure: Occurrence of ischemic cerebrovascular events
timeFrame: baseline, 3-month and 1-year follow-up
Secondary outcomes:
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: baseline, 3-month and 1-year follow-up
measure: MMSE (Mini Mental State Examination)
timeFrame: baseline, 3-month and 1-year follow-up
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline, 3-month and 1-year follow-up
measure: The Stroop Color Test
timeFrame: baseline, 3-month and 1-year follow-up
measure: CTT (Color Trail Test)
timeFrame: baseline, 3-month and 1-year follow-up
measure: CDT (Clock drawing test)
timeFrame: baseline, 3-month and 1-year follow-up
measure: VFT (Verbal Fluency Test)
timeFrame: baseline, 3-month and 1-year follow-up
measure: HAMD (Hamilton Depression Scale)
timeFrame: baseline, 3-month and 1-year follow-up
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: baseline, 3-month and 1-year follow-up
measure: MRI measure- resting state MRI images
timeFrame: baseline, 3-month and 1-year follow-up
measure: MRI measures-structural phase MRI images
timeFrame: baseline, 3-month and 1-year follow-up
measure: MRI measures-3D pCASL images
timeFrame: baseline, 3-month and 1-year follow-up
measure: Ultrasound measures-MCA-PI (middle cerebral artery-pulsatility index)
timeFrame: baseline, 3-month and 1-year follow-up
measure: Ultrasound measures-IMT (intima-media thickness)
timeFrame: baseline, 3-month and 1-year follow-up
measure: Blood Metabolomics measures-CRP (C-reactive protiein)
timeFrame: baseline, 3-month and 1-year follow-up
measure: Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)
timeFrame: baseline, 3-month and 1-year follow-up
measure: Blood Metabolomics measures-miRNA/microRNA
timeFrame: baseline, 3-month and 1-year follow-up
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: