Cognitive Outcomes in Patients With Branch Atheromatous Disease-Related Stroke: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mini-Mental State Examination (MMSE) score at 1 year after enrollment
研究概览
简要总结
Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration and poor functional outcomes, and BAD is increasingly recognized as an independent disease entity. However, the association between BAD and cognitive impairment remains unclear. This nationwide, multicenter, prospective observational study will prospectively collect epidemiological, clinical, neuroimaging, functional, and cognitive outcome data from patients with BAD. The study aims to investigate the occurrence of cognitive impairment after BAD and identify the clinical and neuroimaging characteristics associated with cognitive impairment. In particular, the relationship between early neurological deterioration (END) and cognitive impairment will be investigated. As an exploratory objective, this study will further explore the potential brain network mechanisms underlying cognitive impairment associated with END events.
详细描述
Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration (END) and poor functional outcomes. However, the association between BAD and long-term cognitive impairment remains unclear.
This nationwide, multicenter, prospective observational study aims to investigate cognitive outcomes after BAD and identify clinical and neuroimaging characteristics associated with cognitive impairment. Patients with BAD will be classified according to END status determined during the acute phase after stroke onset before enrollment. Patients with and without END will then be enrolled in a 1:1 ratio and followed prospectively. The relationship between END status and subsequent cognitive outcomes will be evaluated. As an exploratory objective, this study will investigate potential brain network alterations associated with cognitive impairment after BAD.
Epidemiological data, clinical characteristics, TCD, neuroimaging findings, functional outcomes, cognitive outcomes, clinical events, and medication use during follow-up will be collected. Assessments of cognitive and functional outcomes, conducted by trained, independent, blinded evaluators, will be performed at enrollment and 1 year after enrollment.
Neuroimaging data will be collected from participating centers, including routine clinical imaging data and advanced neuroimaging data. Advanced neuroimaging assessments will include high-resolution 5T MRI sequences acquired at enrollment and 1 year after enrollment, as well as photon-counting CT imaging, including computed tomography angiography (CTA) and computed tomography perfusion (CTP), performed at enrollment. Imaging acquisition protocols and parameters will be standardized across participating centers to ensure consistency and comparability of imaging data.
Baseline is defined as the assessment performed at enrollment. Cognitive assessments performed at enrollment (8-14 days after stroke onset) will serve as the baseline assessment and represent early post-stroke cognitive status. Independent centralized adjudication committees will be established for cognitive assessment and neuroimaging evaluation, with members blinded to the other's findings and all clinical information.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-80 years.
- •Time from onset to enrollment: 8-14 days; if onset time is unknown, time from last known normal to enrollment must be 8-14 days.
- •Meet the following imaging inclusion criteria:
- •3. 1 DWI infarct: single (isolated) deep (subcortical) infarct 3.2 The culprit vessel is the lenticulostriate artery, and the DWI lesion meets at least one of the following criteria (A/B): A. comma-shaped infarct expanding fan-wise from bottom to top on coronal view; or B. involvement of ≥3 axial slices (slice thickness 5-7 mm) 3.3 No ≥50% stenosis of the ipsilateral middle cerebral artery (confirmed by MRA, CTA, or DSA)
- •Informed consent form signed by the patient or their legally authorized representative.
排除标准
- •Baseline imaging showing intracranial hemorrhagic disease, vascular malformation, space-occupying lesion, or other non-ischemic intracranial pathology.
- •Transient ischemic attack or stroke mimics.
- •Cardioembolic causes: including atrial fibrillation, valvular heart disease, infective endocarditis, etc.
- •Tandem extracranial vascular stenosis ≥50% ipsilateral to the infarct lesion.
- •Prior diagnosis of dementia (Alzheimer's disease, frontotemporal dementia, or Lewy body dementia) or significant cognitive decline (IQCODE > 3.38).
- •Contraindications to photon-counting CT or 5T-MRI.
- •Pregnancy or lactation.
- •Life expectancy < 1 year.
研究组 & 干预措施
END group
Patients with branch atheromatous disease (BAD)-related stroke who develop early neurological deterioration (END) within 7 days after stroke onset. END is defined as an increase in NIHSS total score of ≥4 points or an increase in motor NIHSS score of ≥2 points.The baseline NIHSS score for END assessment is defined as the first NIHSS evaluation performed and documented by a clinician after stroke onset. END will be assessed within 7 days after stroke onset. Deterioration due to intracranial hemorrhage will not be considered as END.
干预措施: END exposure (Other)
Non-END group
Patients with branch atheromatous disease (BAD)-related stroke who do not meet the predefined criteria of END.
结局指标
主要结局
Mini-Mental State Examination (MMSE) score at 1 year after enrollment
时间窗: At 1 year after enrollment
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE). The total MMSE score ranges from 0 to 30 points, with higher scores indicating better global cognitive function. Lower scores indicate greater cognitive impairment after BAD-related stroke.
次要结局
- Montreal Cognitive Assessment (MoCA) score(At enrollment and 1 year after enrollment)
- Mini-Mental State Examination (MMSE) score(At enrollment)
- Trail Making Test Part A(At enrollment and 1 year after enrollment)
- Trail Making Test Part B (TMT-B)(At enrollment and 1 year after enrollment)
- Auditory Verbal Learning Test (AVLT) score(At enrollment and 1 year after enrollment)
- Digit Span Test score(At enrollment and 1 year after enrollment)
- Animal Fluency Test score(At enrollment and 1 year after enrollment)
- Modified Rey-Osterrieth Figure Copy Test score(At enrollment and 1 year after enrollment)
- Simple Reaction Time Task score(At enrollment and 1 year after enrollment)
- Facial Emotion Recognition Test score(At enrollment and 1 year after enrollment)
- Change from baseline in Mini-Mental State Examination (MMSE) score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Montreal Cognitive Assessment (MoCA) score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Trail Making Test Part A (TMT-A) completion time at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Trail Making Test Part B (TMT-B) completion time at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Auditory Verbal Learning Test (AVLT) score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Digit Span Test score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Animal Fluency Test score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Modified Rey-Osterrieth Figure Copy Test score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Simple Reaction Time Task reaction time at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Change from baseline in Facial Emotion Recognition Test score at 1 year after enrollment(At enrollment and 1 year after enrollment)
- Ischemic stroke(Within 1 year after enrollment)
- Intracerebral hemorrhage(Within 1 year after enrollment)
- Stroke(Within 1 year after enrollment)
- Myocardial infarction(Within 1 year after enrollment)
- All-cause mortality(Within 1 year after enrollment)
- Bleeding events(Within 1 year after enrollment)
- Major bleeding(Within 1 year after enrollment)
- Modified Rankin Scale (mRS) score(At 1 year after enrollment)
- Barthel Index (BI) score(At 1 year after enrollment)