Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- National Institute of Health stroke scale
研究概览
简要总结
Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study
详细描述
This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the AIS diagnostic criteria;
- •Age 18-80;
- •Within 7 days of the onset;
- •Signing the informed consent, providing relevant medical history and biological specimens.
排除标准
- •mRS > score 2 before onset;
- •Serious systemic diseases including malignant tumors;
- •Hematological diseases and autoimmune diseases;
- •ALT or AST > 2 times the upper limit of normal value or severe liver disease;
- •Serum creatinine > 1.5 times the upper normal limit or severe nephropathy;
- •History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning);
- •History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital;
- •Antibiotic use within 1 month before admission;
- •Fece cannot be obtained within 4 days after admission.
结局指标
主要结局
National Institute of Health stroke scale
时间窗: 3 months after the onset
An evaluation of neurological deficits
modified Rankin Scale
时间窗: 3 months after the onset
An evaluation of neurological deficits
Major ischemic events
时间窗: within 3 months
Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
次要结局
- Major ischemic events(within 12 months)
- modified Rankin Scale(12 months after the onset)
- National Institute of Health stroke scale(12 months after the onset)
研究者
yinjia
Chief Physician
Nanfang Hospital, Southern Medical University