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A Multi-center Prospective Study of Branch Atheromatous Disease in China | Clinical Trials | Clareo Health

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A Multi-center Prospective Study of Branch Atheromatous Disease in China

NCT04973774•Peking Union Medical College Hospital

Summary

Branch atheromatous disease (BAD), is regarded as one of the important etiologies for acute isolated subcortical infarction, especially in Asian population. However, due to the fact that the existing imaging techniques cannot depict small vessel changes, the clinical diagnosis, therapy and research of BAD are facing challenges. We have started a multi-center prospective observational study of BAD in China, aiming at establishing a large-sample clinical-radiological cohort of BAD, analyzing predictors for functional outcome, and exploring the efficacy of tirofiban on BAD. A standardized Case Report Form (and eCRF on website) is used to collect baseline and follow-up information on epidemiological, clinical, radiological（MRI, SWI, MRA, HRMRI,3TVWI）and blood test. The primary outcome was mRS on 90 days with blind evaluation.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age:18-80years
•2. Acute cerebral infarction:if the clinical manifestations are TIA, new infarct lesions should be found on DWI at the same time.
•3. The time from onset to enrollment is less than 72 hours. If the onset time was unknown, the time of last known free of new ischemic symptoms to enrollment is less than 72h.
•4. Meet the following radiological criterial： 1) DWI infarct: single (isolated) deep (subcortical) infarct. 2) The culprit vessels are the lenticulostriate artery or the para-pontine median artery, and the infarct lesion on DWI conforms to one of the following characteri stics(A/B): A. Lenticulostriate artery: ① "comma-like" infarct lesions with "fan-shaped" extension from bottom to top in the coronary position; OR ② ≥3 layers (layer thickness 5-7 mm) on axial DWI images of the head; B. Para-pontine median artery: the infarct lesion extends from the deep pons to the ventral pons on the axial DWI of the head.
•3\) No ≥50% stenosis on the parent artery of the criminal vessel (i.e. corresponding basilar or middle cerebral artery) (confirmed by MRA or CTA or DSA).
•5.Signed informed consent by the patient or legally authorised representatives

Exclusion Criteria

•1. Intracranial hemorrhagic diseases, vascular malformations, aneurysms, brain abscesses, malignant space occupying lesions or other non-ischemic intracranial lesions observed by baseline head CT and MRI, MRA/CTA/DSA;
•2. There was ≥50% stenosis of extracranial vessels with ipsally serial relationship
•3. Cardiogenic embolism: atrial fibrillation, myocardial infarction, valvular heart disease, dilated cardiomyopathy, infective endocarditis, atrioventricular block disease, heart rate less than 50 beats /min
•4. Have received or plan to receive acute endovascular treatment after onset of the disease
•5. stroke caused by other clear causes, such as moyamoya disease, arterial dissection, vasculitis, etc
•6. mRS score prior to the onset of the disease was ≥2 points
•7. Known malignant tumor
•8. Life expectancy ≤6 months
•9. Can not tolerate 3T MRI examination
•10. Pregnant or lactating women
+1 more criteria

Locations (1)

Shengde li

Beijing, Beijing Municipality, China

Key Dates

Start Date

June 1, 2021

Primary Completion Date

May 31, 2023

Completion Date

June 1, 2025

Last Updated

August 4, 2021

Enrollment

600

ESTIMATED participants

Conditions

Cerebral InfarctionDiseaseMagnetic Resonance Imaging

Contacts

Shengde Li, PhD,MD

CONTACT

17896002828 lishengde.medicine@qq.com

Jun Ni, Phd,MD

CONTACT

8601069154059 pumchnijun@163.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 4, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multi-center Prospective Study of Branch Atheromatous Disease in China

Inclusion Criteria

Exclusion Criteria

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