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

NCT06584565 | Recruiting

• 1 other identifier: NFEC-2024-150
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke, Acute

Keywords

Stroke recurrence; Post-stroke cognitive impairment; Post-stroke depression

Outcome Measures

Primary Outcomes (1)

• Incidence of new cardiovascular events and death

  any stroke /TIA/ myocardial infarction/Vascular death

  within 12 months after onset

Secondary Outcomes (10)

• Brain Injury Conditions

  3, 12 months after ischemic stroke

• Small Vessel Disease Burden

  3, 12 months after ischemic stroke

• Cerebrovascular Pathology

  3, 12 months after ischemic stroke

• Modified Rankin Scale ( mRS ) score

  7 day and 3, 12 months after ischemic stroke

• National Institutes of Health Stroke Scale ( NIHSS ) score

  7 day and 3, 12 months after ischemic stroke

Study Arms (2)

modeling queue

The modeling queue is used to manage and prioritize tasks related to the development and training of models.

Other: microbiome; metabolomics; proteomics

validation queue

The validation queue is designed to handle tasks related to the evaluation and validation of models.

Other: microbiome; metabolomics; proteomics

Interventions

microbiome; metabolomics; proteomics OTHER

post-stroke change of microbiome; metabolomics; proteomics

modeling queue; validation queue

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Severe impairment of consciousness (awareness score of NIHSS\>1)
• History of stroke within 12 months
• Severe systemic disease including malignancy
• 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
• 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
• Unable to collect a stool specimen within 4 days of admission
• Assessed to be unsuitable for participation in this study by the investigator

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Nanfang Hospital,Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, stool

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Central Study Contacts

Jia Yin, M.D

CONTACT

13802964883; jiajiayin@139.com

Weike Hu, M.D

CONTACT

18326349212; weike946@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 5, 2024
• Study Start: January 30, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: September 5, 2024

Record last verified: 2024-09

Locations

CN (1)