Comparing medical treatment effects in patients with intracranial atherosclerosis
Effects of Medical Treatment of Intracranial Atherosclerotic Diseases Based on Magnetic Resonance Fractional Flow Reserve
This study is testing how well standard medical treatment works for people with symptomatic intracranial atherosclerosis to see if it can help prevent strokes or death over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Xuanwu Hospital, Beijing Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT06196398 on ClinicalTrials.gov |
What this trial studies
This multicenter prospective cohort study evaluates the impact of medical treatment on patients with symptomatic intracranial atherosclerosis (ICAS) over one year. Patients are divided into groups based on hemodynamic status assessed by Magnetic Resonance Fractional Flow Reserve (MR-FFR). The primary outcome measures include the occurrence of ischemic stroke or death related to the artery territory within the study period. Standard medical treatment, including anti-platelet therapy, will be administered to all participants.
Who should consider this trial
Good fit: Ideal candidates are patients aged 30 to 80 with symptomatic ICAS lesions in the anterior circulation and 50% to 99% stenosis confirmed by imaging.
Not a fit: Patients with previous cerebrovascular interventions, large cerebral infarctions, or other significant neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with intracranial atherosclerosis, potentially reducing the risk of stroke and death.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in assessing hemodynamic factors in stroke prevention, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged from 30 to 80 with symptomatic ICAS lesion in anterior circulation. 2. 50% to 99% stenosis (in accordance with modified WASID method) confirmed by DSA, CTA or MRA. 3. mRS 0-2 points 4. Informed of the study protocol and objectives. Exclusion Criteria: 1. Previous endovascular treatment or surgery for cerebrovascular diseases 2. Large cerebral infarction (more than 1/2 MCA perfusion area) according to MRI 3. Combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection. 4. Pregnancy or in the preparation for pregnancy 5. Patients who cannot tolerate or do not allow MR screening, including metal implanting and claustrophobia 6. Contraindication for antiplatelet drugs or statins 7. Patients with severe dementia or mental disorders, who cannot cooperate with examination
Where this trial is running
Beijing, Beijing
- Xuanwu Hospital, Capital Medical University — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Jichang Luo
- Email: luojichang_dr@sina.com
- Phone: +8613120136577
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.