Dynamic Changes in Human Microbiome Predict the Risk of Adverse Outcomes in Patients With Acute Ischemic Stroke: a Multicenter Prospective Cohort Study

NCT06240468 | Unknown

• 1 other identifier: CALM2003
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

(1) The main purpose To explore the predictive value of human microbiome and its metabolome for adverse prognosis in patients with acute ischemic stroke (AIS). (2) Secondary purposes

1. 1.To explore the characteristics of cross-regional disturbance of human microbiome in stroke patients;
2. 2.To investigate the characteristics and rules of bacterial flora changes before and after recurrent apoplexy;
3. 3.Markers closely related to AIS prognosis and cognitive emotional complications were excavated by metagenomic, metabolic, peptide and imaging groups.
4. 4.To explore the relationship between serum markers of ultra early stage and prognosis.

Conditions

Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (2)

• All scale surveys were completed at 3, 6 and 12 months after admission

  To evaluate the prognosis of neurological function (mRS, NIHSS), the incidence of new cardiovascular and cerebrovascular events and death (any stroke /TIA/ myocardial infarction) at admission and 3, 6 and 12 months after admission;To evaluate the prognosis of neurological function (mRS, NIHSS), the incidence of new cardiovascular and cerebrovascular events and death (any stroke /TIA/ myocardial infarction) at admission and 3, 6 and 12 months after admission;

  The evaluation time was during admission, three months follow-up, six months follow-up and twelve months follow-up.

• Number of participants with recurrent stroke within one year of follow-up period

  Participants who had recurrent stroke and were readmitted within one year of follow-up.

  The follow-up period is one year.

Study Arms (3)

AIS patient

AIS inclusion criteria (1) Inclusion criteria 1. Meet the diagnostic criteria for AIS or TIA; 2. Age 18-80 years old; 3. within 7 days of the onset of stroke; 4. Sign informed consent, provide relevant medical history and biological specimens; 5. Have lived in the local city for the last three years. (2) Exclusion criteria 1. Patients with recurrent stroke within the past year when first enrolled; 2. mRS \> 2 points before stroke onset; 3. malignant tumor; 4. Liver and kidney dysfunction (alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal, creatinine \> 1.5 times the upper limit of normal); 5. History of drug abuse and chemical poisoning (e.g. pesticide poisoning); 6. In the acute stage of stroke (within 7 days from the onset of stroke) stool specimens could not be collected.

Other: not have

Cognitive/emotional subcohort

(I) Inclusion criteria: 1. It has been included in the AIS queue, meeting the inclusion criteria of the main AIS queue; 2. NIHSS≤15; (II) Exclusion criteria: (1) Patients with aphasia and unable to cooperate in completing the cognitive/emotional assessment during the study; (2) previous severe mental disorder and dementia (AD8 scale score ≥2); (3) A history of severe anxiety and depression; (4) Previous history of seizures.

Other: not have

healthy person

health

Other: not have

Interventions

not have OTHER

not have

AIS patient; Cognitive/emotional subcohort; healthy person

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ischemic stroke

You may qualify if:

• Meet the diagnostic criteria for AIS or TIA
• Age 18-80 years old
• Within 7 days of the onset of stroke
• Sign informed consent, provide relevant medical history and biological specimens
• Have lived in the local city for the last three years

You may not qualify if:

• Patients with recurrent stroke within the past year when first enrolled
• mRS \> 2 points before stroke onset
• malignant tumor
• Liver and kidney dysfunction (alanine aminotransferase or aspartate aminotransferase \>2 times the upper limit of normal, creatinine \> 1.5 times the upper limit of normal)
• History of drug abuse and chemical poisoning (e.g. pesticide poisoning)
• In the acute stage of stroke (within 7 days from the onset of stroke) stool specimens could not be collected

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, urine, stool, mouth swab

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Mengxi Li

CONTACT

15013048680; 1135621389@qq.com

Study Design

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

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: February 5, 2024
• Study Start: February 10, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2025
• Last Updated: February 5, 2024

Record last verified: 2023-05

Locations

CN (1)