Actively Recruiting

Age: 18Years - 75Years
All Genders
ID06584565

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

Led by Nanfang Hospital, Southern Medical University · Updated on 2024-09-05

400

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating acute ischemic stroke (AIS), a serious brain vascular disease with high rates of occurrence, recurrence, disability, and death, especially in China. This study focuses on the complex causes of AIS by analyzing changes in patients' proteins, gut microbes, and metabolites to better predict prognosis and the risk of stroke coming back. By combining data from multiple molecular levels and using machine learning, they aim to develop early prediction models to improve patient care. The study collects blood and fecal samples from AIS patients across multiple centers to perform detailed proteomic, microbiome, and metabolomic testing. Patients are placed into groups called the modeling queue and validation queue to manage the development and evaluation of prediction models. This approach integrates experimental data and computational methods to identify key molecules and possible new targets for intervention, as well as to explore strategies for preventing stroke recurrence. Participants are followed for up to 12 months after their stroke, with assessments at 7 days, 3 months, and 12 months to track brain injury, vascular changes, neurological and cognitive function, daily living abilities, and emotional wellbeing. Researchers monitor the occurrence of new cardiovascular events and deaths within 12 months. The study involves collecting detailed medical histories, biological samples, and using standardized scales such as NIHSS, mRS, MMSE, MOCA, HAMD, and HAMA to evaluate patient outcomes and the predictive value of multi-omics data.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the diagnostic criteria of acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018
  • Aged 18 to 75 years old
  • Stroke occurred within 7 days of onset
  • Provide informed consent, relevant medical history, and biological specimens
Not Eligible

You will not qualify if you...

  • Severe impairment of consciousness (awareness score of NIHSS >1)
  • History of stroke within 12 months
  • Severe systemic disease including malignancy
  • ALT or AST more than 2 times the upper limit of normal or severe liver disease
  • Creatinine more than 1.5 times the upper limit of normal or severe kidney disease
  • History of long-term alcohol use, drug use, or chemical poisoning
  • History of intestinal tumors, irritable bowel syndrome, or inflammatory bowel disease
  • Unable to provide a stool specimen within 4 days of admission
  • Assessed as unsuitable for participation by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Within 7 days of stroke onset

Participants undergo collection of fecal and blood samples for multi-omics analysis including microbiome, metabolomics, and proteomics to evaluate post-stroke molecular changes.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 12 months after stroke onset

Participants are monitored for stroke prognosis, recurrence risk, and related clinical outcomes over time with repeated assessments.

Visits at 7 days, 3 months, and 12 months after stroke onset

Trial Site Locations

Total: 1 location

1

Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, China, 510515

Actively Recruiting

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Research Team

J

Jia Yin, M.D

W

Weike Hu, M.D

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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