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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04973774
Other study ID # BADstudy
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 1, 2025

Study information

Verified date July 2021
Source Peking Union Medical College Hospital
Contact Shengde Li, PhD,MD
Phone 17896002828
Email lishengde.medicine@qq.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date June 1, 2025
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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: ? "comma-like" infarct lesions with "fan-shaped" extension from bottom to top in the coronary position; OR ? =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 11. Participation in another clinical within 3 months before enrollment, or taking part in another ongoing study.

Study Design


Locations

Country Name City State
China Shengde li Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary modified ranking score modified ranking score on 90 days, range:0-6scores; higher score means worse outcome 90 days
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