A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke

Nanfang Hospital, Southern Medical University

Status

Enrolling

Conditions

Ischemic Stroke, Acute

Treatments

Other: microbiome; metabolomics; proteomics

Study type

Observational

Funder types

Other

Identifiers

NCT06584565

NFEC-2024-150

Details and patient eligibility

About

Through a multicenter prospective AIS cohort study, we analyze the potential association of human proteome, microbiome and metabolome alterations with AIS prognosis, searching for key proteins, differential organisms and metabolites, combining experimental data at multiple molecular levels with computational models, and establishing early prediction models through machine learning-based prediction algorithms. While closely tracking the recurrence of stroke in AIS patients, we evaluate the predictive value of human proteome, microbiome and metabolites for stroke recurrence through a nested case-control study, which provides key reference information for exploring the unknown residual risk of AIS recurrence.

Full description

Currently, the burden of brain vascular disease in China is the highest in the world, and among them, the incidence rate of acute ischemic stroke (AIS) is high, the recurrence rate is high, the disability rate is high, the mortality rate is high, and the social burden is heavy. With the increasing number of AIS patients, how to effectively prevent and treat them is a huge challenge facing us. The occurrence and development of AIS are caused by the joint action of multiple risk factors and mutual influence, and single technical means are difficult to deeply explore its complex mechanism. Therefore, building a risk prediction model for poor prognosis and recurrence based on multi-omics technology and layering risk factors for patients are the important research directions for the future. This study aims to establish a multi-center cohort by collecting fecal and blood samples from AIS patients and conducting proteomic, microbial and metabolomic detection. It records the prognosis and recurrence events and uses cross-omics analysis technology to explore the multi-omics network molecular mechanism and screen for new intervention targets. It establishes an early prediction model and explores the stroke secondary prevention strategy based on multi-omics data.

Enrollment

400 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meet the diagnostic criteria of AIS according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018
Aged 18 to 75 years old
Stroke within 7 days of onset
Sign informed consent, provide relevant medical history information and provide biological specimens

Exclusion criteria

Severe impairment of consciousness (awareness score of NIHSS>1)
History of stroke within 12 months
Severe systemic disease including malignancy
ALT or AST> 2 times the upper limit of normal or severe liver disease
creatinine > 1.5 times the upper limit of normal or severe kidney disease
History of long-term drinking, drug use, and chemical poisoning (e.g., pesticide poisoning); Note: Long-term alcohol consumption, usually more than 5 years, over 40 g/day of alcohol for men and 20 g/day for women, or a history of heavy alcohol consumption within 2 weeks, over 80 g/day of alcohol
History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease or confirmed in the hospital
Unable to collect a stool specimen within 4 days of admission
Assessed to be unsuitable for participation in this study by the investigator