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

September 3, 2024 updated by: Nanfang Hospital, Southern Medical University
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Currently, the burden of brain vascular disease in China is the highest in the world, and among them, the incidence rate of acute ischemic stroke (AIS) is high, the recurrence rate is high, the disability rate is high, the mortality rate is high, and the social burden is heavy. With the increasing number of AIS patients, how to effectively prevent and treat them is a huge challenge facing us. The occurrence and development of AIS are caused by the joint action of multiple risk factors and mutual influence, and single technical means are difficult to deeply explore its complex mechanism. Therefore, building a risk prediction model for poor prognosis and recurrence based on multi-omics technology and layering risk factors for patients are the important research directions for the future. This study aims to establish a multi-center cohort by collecting fecal and blood samples from AIS patients and conducting proteomic, microbial and metabolomic detection. It records the prognosis and recurrence events and uses cross-omics analysis technology to explore the multi-omics network molecular mechanism and screen for new intervention targets. It establishes an early prediction model and explores the stroke secondary prevention strategy based on multi-omics data.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital，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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
modeling queue
The modeling queue is used to manage and prioritize tasks related to the development and training of models.
Other: microbiome; metabolomics; proteomics
post-stroke change of 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
post-stroke change of microbiome; metabolomics; proteomics

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of new cardiovascular events and death
Time Frame: within 12 months after onset
any stroke /TIA/ myocardial infarction/Vascular death
within 12 months after onset

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Brain Injury Conditions
Time Frame: 3, 12 months after ischemic stroke
Clinical investigators evaluate brain injury conditions according to head CT or MR, which including the signs of infarct lesions, hemorrhagic transformation post-infarction or cerebral edema.
3, 12 months after ischemic stroke
Small Vessel Disease Burden
Time Frame: 3, 12 months after ischemic stroke
Clinical investigators evaluate small vessel disease burden according to head CT or MR, which including the signs of white matter degeneration, lacunar infarctions, cerebral microbleeds or enlarged perivascular spaces.
3, 12 months after ischemic stroke
Cerebrovascular Pathology
Time Frame: 3, 12 months after ischemic stroke
Clinical investigators evaluate cerebrovascular pathology according to head CT or MR, which including the signs of vascular stenosis, vascular dissection or collateral circulation compensation.
3, 12 months after ischemic stroke
Modified Rankin Scale ( mRS ) score
Time Frame: 7 day and 3, 12 months after ischemic stroke
The MRS score is primarily used to measure the degree of disability and daily living ability of patients. The MRS score ranges from 0 to 6, with a total of 7 levels. The higher the score, the more severe the disability and the worse the prognosis.
7 day and 3, 12 months after ischemic stroke
National Institutes of Health Stroke Scale ( NIHSS ) score
Time Frame: 7 day and 3, 12 months after ischemic stroke
The NIHSS score is commonly used to assess the degree of neurological impairment in patients with acute stroke. The NIHSS consists of 11 items, with a total score ranging from 0 to 42. Each item has different scoring criteria, typically ranging from 0 (normal) to 4 (most severe).
7 day and 3, 12 months after ischemic stroke
Activity of Daily Living Scale ( ADL ) score
Time Frame: 7 day and 3, 12 months after ischemic stroke
The ADL score is primarily used to measure a person's ability to perform basic daily activities. This study uses the Barthel Index scoring method, which ranges from 0 to 100 points, with scoring items including eating, bathing, grooming, dressing, bowel control, bladder control, toileting, transferring, mobility and stairs. A higher score indicates greater independence, while a lower score indicates greater dependence.
7 day and 3, 12 months after ischemic stroke
Mini-mental State Examination ( MMSE ) score
Time Frame: 3, 12 months after ischemic stroke
The MMSE (Mini-Mental State Examination) is a tool used to assess cognitive function, including orientation, memory, attention, language skills, calculation ability, and visuospatial skills. It is commonly used to screen for dementia in older adults. The MMSE has a total score of 30 points: a score of 24-30 suggests normal cognitive function, 18-23 indicates mild cognitive impairment, and 0-17 indicates moderate to severe cognitive impairment.
3, 12 months after ischemic stroke
Montreal Cognitive Assessment ( MOCA ) score
Time Frame: 3, 12 months after ischemic stroke
The MoCA is a tool used to assess cognitive impairment. Compared to the MMSE, the MoCA is more sensitive, particularly for detecting mild cognitive impairment (MCI). The MoCA has a total score of 30 points: a score of 26-30 suggests normal cognitive function, 18-25 indicates mild cognitive impairment (MCI), and 0-17 indicates moderate to severe cognitive impairment. Typically, individuals with lower educational levels (less than 12 years of education) receive an additional point as an adjustment to their total score.
3, 12 months after ischemic stroke
Hamilton Depression Scale ( HAMD ) score
Time Frame: 3, 12 months after ischemic stroke
The HAMD is a clinical scale used to assess the severity of depression. This study uses the 17-item version (HAMD-17), which covers a range of symptoms, including mood, sleep, appetite, and somatic symptoms. The total score ranges from 0 to 52, with each item rated based on the severity of symptoms, typically from 0 (no symptoms) to 4 (severe symptoms).
3, 12 months after ischemic stroke
Hamilton Anxiety Scale ( HAMA ) score
Time Frame: 3, 12 months after ischemic stroke
The HAMA is a clinical scale used to assess the severity of anxiety symptoms. It consists of 14 items, each evaluating different symptoms related to anxiety. These symptoms cover both psychological and somatic manifestations of anxiety. Each item is rated based on the severity of symptoms, with scores ranging from 0 (no symptoms) to 4 (very severe symptoms).
3, 12 months after ischemic stroke

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nanfang Hospital, Southern Medical University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NFEC-2024-150

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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