Cognitive Decline and Underlying Mechanisms in Symptomatic Intracranial Artery Stenosis Patients: A Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorAnhui Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years
Severe stenosis (≥70%-99%) of atherosclerotic internal carotid artery (C6 segment, C7 segment) or middle cerebral artery (M1 segment) confirmed by digital subtraction angiography (DSA) or at least two of the following non-invasive examinations: magnetic resonance angiography (MRA), computed tomography angiography (CTA), or transcranial Doppler (TCD)
Transient ischemic attack (TIA) or minor stroke (National Institute of Health Stroke Scale [NIHSS] score ≤ 4 points)
Right-handed and able to cooperate in neuropsychological tests
Disqualifiers
Other diseases that affect cognitive function, such as cerebral hemorrhage, •Parkinson's disease, neurosyphilis, dementia, tumors, etc.
Right upper limb hemiplegia, aphasia, visual field defects, or visual impairments
More than 50% stenosis of the extracranial internal carotid artery, the vertebral artery, or the basilar artery
Vasculitis, moyamoya disease, and cardiogenic stroke
Trial 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) with transient ischemic attack or minor stroke(NIHSS≤4 points).The degree of stenosis was measured by transcranial doppler, computed magnetic resonance angiography (MRA),tomography angiography (CTA) and digital subtraction angiography (DSA).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
DrugAll patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Endovascular therapy,Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin
Procedure/SurgeryAll patients underwent endovascular therapy and received standard medical management after surgery, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Surgery Group1 intervention
Group B: Medical group1 intervention
Trial outcomes
Primary outcomes
1
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 symptomatic ICAS to evaluate the immediate, delayed and recognition memory of patients with ICAS.
Time frame
baseline, 3-month and 1-year follow-up2
Occurrence of ischemic cerebrovascular events
The changes in occurrence of ischemic cerebrovascular events constitute another major indicator of research result. The new responsible cerebrovascular events during the follow-up period are also the clinical information the investigators pay attention to, including transient ischemic attack (TIA) and stroke.
Time frame
baseline, 3-month and 1-year follow-upSecondary outcomes
1
MoCA (Montreal Cognitive Assessment)
The changes in MoCA will constitute the secondary research outcome. MoCA was based on clinical experience and reference to the MMSE cognitive items and scores, and the final version was finalized in November 2004. The investigators adopted a localized version (Mandarin-8.1 version) in line with the Chinese cultural background. It includes 11 inspection items in 8 cognitive fields, including visual structure skills, executive function, naming, attention and calculation, language, abstract thinking, memory, and orientation. With a total score of 30 or more than 26, it is normal. Anyone who has been education for less than 12 years will need to add one point to his final score. The final score of the higher the better.
Time frame
baseline, 3-month and 1-year follow-up2
MMSE (Mini Mental State Examination)
The changes in MMSE will also constitute the secondary research outcome. The full name of MMSE is mini-mental state examination, and the scale consists of 30 subjects, include the following seven aspects: time orientation, place orientation, immediate memory, attention and calculation, delay memory, language, visual space. One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answer he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up.
Time frame
baseline, 3-month and 1-year follow-up3
DST (Digital Span Test; Forward and Backward)
The changes in DST will constitute the secondary research outcome. Digital span test (DST) was commonly used to evaluate attention ability and instantaneous memory ability. There are two types of test: forward (0-14) and backward (0-13). In the forward test, the subjects were asked to retell the the digits immediately after hearing it until they could not be repeated correctly. In backward test, the subjects were asked to repeat a set of numbers in reverse order until they could not be repeated correctly. The length of the last set of Numbers correctly repeated by the subjects was the final score, forward and backward are counted separately. The higher the score, the better. In this study, the investigators suspect that scores would decrease after follow-up.
Time frame
baseline, 3-month and 1-year follow-up4
The Stroop Color Test
The changes in The Stroop color test will constitute the secondary research outcome measure. The Stroop color word test was developed by Stroop in 1935 and is used to evaluate the attention function of the subject. The subject is required to correctly read the target color on the stimulus card and record the completion time. The final completion time is the score of the participant. The shorter the time used, the better the performance of the subjects
Time frame
baseline, 3-month and 1-year follow-upSponsors and contacts
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Source ClinicalTrials.gov