Cognitive Outcomes in BAD-related Stroke

ConditionsBranch Atheromatous Disease Cognitive Deterioration, Clinical

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorPeking Union Medical College Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

This is an observational study. The study population will include adults aged 18 to 80 years with BAD-related stroke who are enrolled within 8 to 14 days after stroke onset. END status is determined before enrollment based on clinical deterioration occurring within 7 days after stroke onset, according to predefined criteria. Patients with and without END will be enrolled in 1:1 ratio.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

END exposure
Other intervention
It is not an intervention. It is an exposure. END is defined as an increase in NIHSS total score of ≥4 points or an increase in motor NIHSS score of ≥2 points within 7 days of stroke onset.Deterioration due to intracranial hemorrhage will not be considered as END.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: END group1 intervention

Group B: Non-END group0 interventions

Trial outcomes

Primary outcomes

Mini-Mental State Examination (MMSE) score 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.

Time frame

At 1 year after enrollment

Secondary outcomes

Montreal Cognitive Assessment (MoCA) score

Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is a standardized cognitive screening tool designed to evaluate multiple cognitive domains, including visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. The total MoCA score ranges from 0 to 30 points, with lower scores indicating poorer cognitive function.

Time frame

At enrollment and 1 year after enrollment

Mini-Mental State Examination (MMSE) score

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.

Time frame

At enrollment

Trail Making Test Part A

Attention and executive function will be assessed using the Trail Making Test Part A (TMT-A). Longer completion time indicates poorer cognitive performance.

Time frame

At enrollment and 1 year after enrollment

Trail Making Test Part B (TMT-B)

Executive function will be assessed using TMT-B. Longer completion time indicates poorer executive function.

Time frame

At enrollment and 1 year after enrollment

Other outcomes

Middle cerebral artery pulsatility index (PI)

Pulsatility index (PI) of the middle cerebral artery will be measured by transcranial Doppler ultrasonography (TCD). Higher PI values indicate increased cerebrovascular resistance and are associated with impaired cerebral perfusion.

Time frame

At 1 year after enrollment

Middle cerebral artery mean flow velocity (Vm)

Mean flow velocity (Vm) of the middle cerebral artery will be measured by transcranial Doppler ultrasonography (TCD). Vm reflects cerebral blood flow velocity. Lower Vm values may indicate reduced cerebral perfusion and impaired cerebral circulation.

Time frame

At 1 year after enrollment

Change from baseline in middle cerebral artery pulsatility index (PI) at 1 year after enrollment

Time frame

At enrollment and 1 year after enrollment

Change from baseline in middle cerebral artery mean flow velocity (Vm) at 1 year after enrollment

Time frame

At enrollment and 1 year after enrollment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: