Correlation Study Between Gut Microbiota and Prognosis in Patients With Intracranial Arterial Stenosis（GROW-ICAS）
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis
研究概览
简要总结
GROW-ICAS (Gut microBiota and prOgnostic Outcomes in IntraCranial Arterial Stenosis) is a prospective observational cohort study that enrolls patients with intracranial arterial stenosis to investigate the correlations between their gut microbiota, metabolomic, and transcriptomic profiles and three key clinical domains: functional outcomes, vascular plaque imaging characteristics, and post-stroke non-motor dysfunctions (including cognitive impairment, depression, anxiety, and fatigue).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-80 years.
- •Intracranial arterial stenosis confirmed by CTA/MRA/DSA.
- •Local residency ≥6 consecutive months.
- •Signed informed consent.
排除标准
- •Tandem extracranial stenosis (≥50%) proximal to the target intracranial stenotic vessel.
- •Non-atherosclerotic intracranial stenosis.
- •Extracranial/intracranial endovascular treatment within 30 days pre-enrollment or planned intervention within 6 months.
- •Intracranial hemorrhage within 90 days pre-enrollment.
- •Pre-existing intracranial tumor, cerebral aneurysm, or arteriovenous malformation.
- •Cardioembolic embolism.
- •Active bleeding/hemorrhagic diathesis.
- •Major surgery within 30 days pre-enrollment or planned within 6 months post-enrollment.
- •Severe neurological deficits impairing independent living or dementia/psychiatric disorders hindering follow-up.
- •Pregnancy/lactation/planned pregnancy.
- •Chronic inflammatory/autoimmune diseases.
- •Uncontrolled hypertension or diabetes.
- •Severe cardiac/hepatic/renal dysfunction, hematologic disorders, malignancy, or life expectancy <1 year.
- •MRI contraindications.
- •History of depression/anxiety/cognitive impairment requiring therapy.
- •Antibiotic/probiotic/glucocorticoid/immunosuppressant use within 1 month pre-enrollment.
- •Current/planned participation in other trials.
- •Inability to cooperate due to psychiatric/emotional disorders.
- •Other investigator-deemed ineligibility.
结局指标
主要结局
Stroke Recurrence in Patients with Symptomatic Intracranial Arterial Stenosis
时间窗: From enrollment to 1 year
Patients with symptomatic intracranial arterial stenosis experiencing recurrent cerebrovascular events, defined as either novel ischemic stroke or transient ischemic attack (TIA).
Stroke Occurrence in Patients with Asymptomatic Intracranial Arterial Stenosis
时间窗: From enrollment to 1 year
Incident cerebrovascular events-comprising ischemic stroke or transient ischemic attack (TIA)-occurring in patients exhibiting asymptomatic intracranial arterial stenosis.
次要结局
- Changes in Imaging Characteristics of Intracranial Vascular Plaques.(From enrollment to 1 year)