Observational study of branch atheromatous disease in China
A Multi-center Prospective Study of Branch Atheromatous Disease in China
This study is testing how well tirofiban works for treating branch atheromatous disease in people with acute strokes in China and looking at what factors might affect their recovery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT04973774 on ClinicalTrials.gov |
What this trial studies
This study focuses on branch atheromatous disease (BAD), a significant cause of acute isolated subcortical infarction, particularly in the Asian population. It aims to establish a large clinical-radiological cohort to analyze predictors for functional outcomes and evaluate the efficacy of tirofiban in treating BAD. Participants will be enrolled based on specific radiological criteria and will undergo comprehensive assessments including MRI and blood tests. The primary outcome will be measured using the modified Rankin Scale (mRS) at 90 days post-enrollment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-80 who have experienced an acute cerebral infarction within the last 72 hours and meet specific radiological criteria.
Not a fit: Patients with conditions unrelated to branch atheromatous disease or those with significant stenosis in the parent artery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding and treatment of branch atheromatous disease, leading to better outcomes for patients with cerebral infarction.
How similar studies have performed: While there is limited data on similar studies, the approach of analyzing predictors and treatment efficacy in BAD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing, Beijing
- Shengde li — Beijing, Beijing, China (Recruiting)
Study contacts
- Principal investigator: Bin Peng, Phd,MD — Peking Union Medical College Hospital
- Study coordinator: Shengde Li, PhD,MD
- Email: lishengde.medicine@qq.com
- Phone: 17896002828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.