NCT06584565Recruiting
A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
Source: ClinicalTrials.gov · Last updated 5 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 400 (estimated)
- First submitted
- 26 Aug 2024
- Start date
- 30 Jan 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Stroke
- NCT number
- NCT06584565
What you commit to
- Study type: Observational
- Planned participants: 400
- From 30 Jan 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe impairment of consciousness (awareness score of NIHSS\>1)
- History of stroke within 12 months
- Severe systemic disease including malignancy
- 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
Lab values
- 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
Other
- Unable to collect a stool specimen within 4 days of admission
- Assessed to be unsuitable for participation in this study by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.