Cognitive Outcomes in BAD-related Stroke

NCT07761182 | Not Yet Recruiting

• 1 other identifier: BADCOG
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Branch Atheromatous Disease; Cognitive; Deterioration, Clinical

Outcome Measures

Primary Outcomes (1)

• 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.

  At 1 year after enrollment

Secondary Outcomes (29)

• 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

Other Outcomes (4)

• Middle cerebral artery pulsatility index (PI)

  At 1 year after enrollment

• Middle cerebral artery mean flow velocity (Vm)

  At 1 year after enrollment

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

  At enrollment and 1 year after enrollment

Study Arms (2)

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.

Other: END exposure

Non-END group

Patients with branch atheromatous disease (BAD)-related stroke who do not meet the predefined criteria of END.

Interventions

END exposure OTHER

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.

END group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.
• \. 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) 4. Informed consent form signed by the patient or their legally authorized representative.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (3)

• Li S, Wang L, Liu B, Zhang P, Zhang J, Chen G, Yang Q, Bian H, Li X, Wu J, Zhao F, Liu S, Bai H, Zhao W, Yue W, Feng K, Tang Y, Lu Z, Li Y, Zhang J, Zhou L, Zhu Y, Ni J, Peng B; BAD-Study Investigators. Clinical and Prognostic Characteristics of Acute BAD-Related Stroke: A Multicenter MRI-Based Prospective Study. Stroke. 2024 Oct;55(10):2431-2438. doi: 10.1161/STROKEAHA.124.047688. Epub 2024 Sep 24.

  PMID: 39315825 BACKGROUND

• El Husseini N, Katzan IL, Rost NS, Blake ML, Byun E, Pendlebury ST, Aparicio HJ, Marquine MJ, Gottesman RF, Smith EE; American Heart Association Stroke Council; Council on Cardiovascular and Stroke Nursing; Council on Cardiovascular Radiology and Intervention; Council on Hypertension; and Council on Lifestyle and Cardiometabolic Health. Cognitive Impairment After Ischemic and Hemorrhagic Stroke: A Scientific Statement From the American Heart Association/American Stroke Association. Stroke. 2023 Jun;54(6):e272-e291. doi: 10.1161/STR.0000000000000430. Epub 2023 May 1.

  PMID: 37125534 BACKGROUND

• Yang T, Deng Q, Jiang S, Yan YY, Yuan Y, Wu SM, Zhang ST, Sun JY, Wu B. Cognitive impairment in two subtypes of a single subcortical infarction. Chin Med J (Engl). 2021 Dec 8;134(24):2992-2998. doi: 10.1097/CM9.0000000000001938.

  PMID: 34908257 BACKGROUND

MeSH Terms

Conditions

Clinical Deterioration

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shengde Li, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shengde Li, MD

CONTACT

861069156371; lishengde.medicine@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: August 12, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)