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

January 25, 2024 updated by: Zhujiang Hospital

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a multicenter, prospective clinical cohort study. In this study, 2000 patients with AIS were continuously enrolled in a multicenter study, and neurological function scores (including NIHSS, mRS And ADL scores) were evaluated during and after hospitalization (3 months, 6 months, 12 months) by outpatient/telephone follow-up, and recurrent stroke and other cardiovascular and cerebrovascular events were recorded. Besides, periodontal swabs, urine, feces and blood samples were collected at multiple time points (Residual blood after the first clinical examination was collected for patients with very early stage, and blood, urine, feces and periodontal swabs were collected the next day after admission, before discharge, 3 months and 6 months after admission. Since the collection time of fecal specimens is difficult to control, only two specimens should be collected 48 hours apart during hospitalization. The first specimen should be collected as early as possible, and the time of specimen separation should be recorded.

Baseline data collection and discharge neurological function score were completed for the enrolled AIS patients before discharge, and the final diagnosis, stroke etiology classification, lifestyle survey (1 year ago), and relevant examination and treatment during hospitalization were recorded. Neurological function score, lifestyle survey, new cardiovascular and cerebrovascular events and biological specimen collection (blood, urine, feces, periodontal swab) were recorded during outpatient visits 3 months and 6 months after admission. Telephone follow-up was conducted 12 months after admission, mRS Score, ADL score and new cardiovascular and cerebrovascular events were recorded.

For the patients (750 cases) who met the criteria for inclusion in the cognitive emotion subcohort, outpatient emotional and cognitive psychological assessment was also required before discharge, 3 months and 6 months after admission on the basis of the AIS cohort.

For the subcohort with recurrence within 1 year, only data collection during hospitalization (baseline hospitalization data) and biological specimen collection during hospitalization (residual blood after the first laboratory examination was retained for patients in the very early stage, and blood, urine, feces, and periodontal swabs were collected the next day after admission and before discharge. As the time of fecal sample collection is difficult to control, it only needs to be 48 hours between hospitalization), and no follow-up will be conducted after discharge.

In addition, 500 patients without stroke were recruited as healthy control group according to the prescribed inclusion criteria.

No randomization or any study protocol-driven treatment will be administered or provided to the subject during the study. If clinically applicable, treatment decisions and treatment options are made at the discretion of the treating physician.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with ischemic stroke

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
not have
healthy person
health
Other: not have
not have

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All scale surveys were completed at 3, 6 and 12 months after admission
Time Frame: The evaluation time was during admission, three months follow-up, six months follow-up and twelve months follow-up.
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
Time Frame: The follow-up period is one year.
Participants who had recurrent stroke and were readmitted within one year of follow-up.
The follow-up period is one year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

January 25, 2024

First Posted (Estimated)

February 5, 2024

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

January 25, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALM2003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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