NCT06584565 A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
| NCT ID | NCT06584565 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Ischemic Stroke, Acute |
| Study Type | OBSERVATIONAL |
| Enrollment | 400 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 400 participants in total. It began in 2024-01-30 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06584565 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Ischemic Stroke, Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584565 currently recruiting?
Yes, NCT06584565 is actively recruiting participants. Contact the research team at jiajiayin@139.com for enrollment information.
Where is the NCT06584565 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06584565 clinical trial?
NCT06584565 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 400 participants.
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