Clinical trial NCT05504330: Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients
Official title: Cognitive Decline and Underlying Mechanisms in Asymptomatic Intracranial Artery Stenosis Patients: A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asymptomatic Intracranial Stenosis
Cognitive Impairment
Cerebrovascular Event
Keywords: Asymptomatic Intracranial Stenosis patients
Cognitive Impairment
Cerebrovascular Event
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2022-08-17
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 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).

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.

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.

Primary outcomes:
measure: The changes in Memory
timeFrame: baseline, 1 and 2 years after follow-up
measure: Occurrence of ischemic cerebrovascular events
timeFrame: baseline, 1 and 2 years after follow-up
Secondary outcomes:
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: baseline, 1 and 2 years after follow-up
measure: MMSE (Mini Mental State Examination)
timeFrame: baseline, 1 and 2 years after follow-up
measure: DST (Digital Span Test; Forward and Backward)
timeFrame: baseline, 1 and 2 years after follow-up
measure: SDMT (Symbol digital modalities test)
timeFrame: baseline, 1 and 2 years after follow-up
measure: The Stroop color test
timeFrame: baseline, 1 and 2 years after follow-up
measure: CTT (Color Trail Test)
timeFrame: baseline, 1 and 2 years after follow-up
measure: ROCF (Rey-Osterrieth Complex Figure)
timeFrame: baseline, 1 and 2 years after follow-up
measure: JoLO (Judgment of Line Orientation)
timeFrame: baseline, 1 and 2 years after follow-up
measure: VFT (Verbal Fluency Test)
timeFrame: baseline, 1 and 2 years after follow-up
measure: BNT (Boston Naming Test)
timeFrame: baseline, 1 and 2 years after follow-up
measure: LANT (Lateralized attention network test)
timeFrame: baseline, 1 and 2 years after follow-up
measure: HAMD (Hamilton Depression Scale)
timeFrame: baseline, 1 and 2 years after follow-up
measure: HAMA (Hamilton Anxiety Scale)
timeFrame: baseline, 1 and 2 years after follow-up
measure: MRI measure- resting state MRI images
timeFrame: baseline, 1 and 2 years after follow-up
measure: MRI measures-structural phase MRI images
timeFrame: baseline, 1 and 2 years after follow-up
measure: MRI measures-3D pCASL images
timeFrame: baseline, 1 and 2 years after follow-up
measure: Ultrasound measures-MCA-PI(middle cerebral artery-pulsatility index)
timeFrame: baseline, 1 and 2 years after follow-up
measure: Ultrasound measures-IMT( intima-media thickness)
timeFrame: baseline, 1 and 2 years after follow-up
measure: Ultrasound measures-BHI(breath-holding index)
timeFrame: baseline, 1 and 2 years after follow-up
measure: Blood Metabolomics measures-CRP(C-reactive protiein)
timeFrame: baseline, 1 and 2 years after follow-up
measure: Blood Metabolomics measures-oxLDL(Oxidized low-density lipoprotein)
timeFrame: baseline, 1 and 2 years after follow-up
measure: Blood Metabolomics measures-miRNA（microRNA）
timeFrame: baseline, 1 and 2 years after follow-up
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: