Intracranial Atherosclerosis, Stroke, Ischemic
Conditions
Keywords
Intracranial atherosclerotic diseases, Fractional Flow Reserve, Hemodynamics, Stroke
Brief summary
This multicenter prospective cohort study aims to compare the difference in the effects of medical treatment within 1 year between the two groups of ICAS patients divided hemodynamically by Magnetic Resonance Fractional Flow Reserve. PC MRA will be applied for FFR measurement. The primary outcome is the composite of ischemic stroke or death related to the qualifying artery territory for 1 year.
Interventions
DRUGStandard Medical Treatment on the basis of anti-platelet therapy
1. Anti-platelet therapy: aspirin 75mg+clopidogrel 100mg will be applied for patients with severe ICAS stenosis (70%-90%) suffering stroke or TIA within 30 days. After 90 days, single anti-platelet therapy will be continued. 2. Intensive statin therapy: Statins with high doses 3. Blood pressure: below 140/90mmHg 4. LDL: less than 1.81mmol/L(70mg/dl) 5. Fasting blood glucose controlled to 5.9mmol/L, and glycosylated hemoglobin A1c reduced to less than 7% 6. Cigarette and alcohol quitting 7. Oral anticoagulants for atrial fibrillation
Sponsors
National Key Research and Development Project, China
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of ischemic stroke or death related to the qualifying artery territory | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional evaluation | 1 year | Modified Rankin Scale score |
Countries
China
Contacts
Primary ContactJichang Luo
Outcome results
None listed