Clinical trial NCT06584565: A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
Official title: A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Stroke, Acute
Keywords: Stroke recurrence
Post-stroke cognitive impairment
Post-stroke depression
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-09-05
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population mainly includes patients who meet the diagnostic criteria for acute ischemic stroke (AIS), are aged between 18 and 75 years, have a stroke onset within the past 7 days, and have clear consciousness. Patients with severe systemic diseases, a recent history of stroke, severe liver or kidney disease, a history of long-term alcohol consumption, those unable to provide a sample, or those assessed by the investigator as unsuitable for participation in the study are excluded.

Brief summary: 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Severe impairment of consciousness (awareness score of NIHSS\>1)
2. History of stroke within 12 months
3. Severe systemic disease including malignancy
4. ALT or AST\> 2 times the upper limit of normal or severe liver disease
5. creatinine \> 1.5 times the upper limit of normal or severe kidney disease
6. 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
7. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease or confirmed in the hospital
8. Unable to collect a stool specimen within 4 days of admission
9. Assessed to be unsuitable for participation in this study by the investigator

Primary outcomes:
measure: Incidence of new cardiovascular events and death
timeFrame: within 12 months after onset
Secondary outcomes:
measure: Brain Injury Conditions
timeFrame: 3, 12 months after ischemic stroke
measure: Small Vessel Disease Burden
timeFrame: 3, 12 months after ischemic stroke
measure: Cerebrovascular Pathology
timeFrame: 3, 12 months after ischemic stroke
measure: Modified Rankin Scale ( mRS ) score
timeFrame: 7 day and 3, 12 months after ischemic stroke
measure: National Institutes of Health Stroke Scale ( NIHSS ) score
timeFrame: 7 day and 3, 12 months after ischemic stroke
measure: Activity of Daily Living Scale ( ADL ) score
timeFrame: 7 day and 3, 12 months after ischemic stroke
measure: Mini-mental State Examination ( MMSE ) score
timeFrame: 3, 12 months after ischemic stroke
measure: Montreal Cognitive Assessment ( MOCA ) score
timeFrame: 3, 12 months after ischemic stroke
measure: Hamilton Depression Scale ( HAMD ) score
timeFrame: 3, 12 months after ischemic stroke
measure: Hamilton Anxiety Scale ( HAMA ) score
timeFrame: 3, 12 months after ischemic stroke
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital,Southern Medical University
state: Guangdong
Study officials:
References: