Clinical trial NCT04978701: Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
Official title: Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: acute ischemic stroke, microbiome, prognosis
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Zhujiang Hospital
name: Guangdong Yanling Hospital
name: Shenzhen University General Hospital
name: The First Hospital Of Qiqihar
name: Huzhou Central Hospital
name: Zhejiang Greentown Cardiovascular Hospital
name: People's Hospital of Leshan, Sichuan Province
First posted: 2021-07-27
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who met the eligibility criteria for acute ischemic stroke

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: modified Rankin Scale
timeFrame: 3 months after the onset
measure: National Institute of Health stroke scale
timeFrame: 3 months after the onset
measure: Major ischemic events
timeFrame: within 3 months
Secondary outcomes:
measure: modified Rankin Scale
timeFrame: 6 months after the onset
measure: National Institute of Health stroke scale
timeFrame: 6 months after the onset
measure: Major ischemic events
timeFrame: within 6 months
measure: modified Rankin Scale
timeFrame: 12 months after the onset
measure: National Institute of Health stroke scale
timeFrame: 12 months after the onset
measure: Major ischemic events
timeFrame: within 12 months
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Department of Neurology, NanFang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Department of Neurology, NanFang Hospital, Southern Medical University
name: Yin Jia, Master
role: PRINCIPAL_INVESTIGATOR
References: