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

NCT ID: NCT04973774

Last Updated: 2021-08-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-06-01

Brief 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.

Conditions

Cerebral Infarction; Disease; Magnetic Resonance Imaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

11. Participation in another clinical within 3 months before enrollment, or taking part in another ongoing study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bin Peng

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bin Peng, Phd,MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Shengde li

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shengde Li, PhD,MD

Role: CONTACT

lishengde.medicine@qq.com

17896002828

Jun Ni, Phd,MD

Role: CONTACT

pumchnijun@163.com

8601069154059

Facility Contacts

Shengde Li, MD,PhD

Role: primary

Other Identifiers

BADstudy

Identifier Type: -

Identifier Source: org_study_id