Analyzing multi-omics data to predict outcomes in acute ischemic stroke patients
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 · NCT06584565
This study is trying to see if analyzing blood and stool samples from people who have had a stroke can help predict their recovery and chances of having another stroke.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06584565 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to analyze the relationship between changes in the human proteome, microbiome, and metabolome with the prognosis and recurrence risk of acute ischemic stroke (AIS). By collecting blood and fecal samples from AIS patients, the study will utilize advanced machine learning algorithms to develop predictive models based on multi-omics data. The research focuses on understanding the complex mechanisms behind AIS and aims to identify new intervention targets for secondary prevention. The study will track patient outcomes and recurrence events to provide valuable insights into AIS management.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 who have experienced an acute ischemic stroke within the last 7 days.
Not a fit: Patients with severe consciousness impairment, recent strokes, or significant systemic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved prediction and prevention strategies for recurrent strokes in patients.
How similar studies have performed: While multi-omics approaches are gaining traction, this specific study represents a novel application in the context of acute ischemic stroke prognosis.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital,Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Jia Yin, M.D
- Email: jiajiayin@139.com
- Phone: 13802964883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ischemic Stroke, Acute, Stroke recurrence, Post-stroke cognitive impairment, Post-stroke depression