Ischemic Stroke, AcuteNCT06584565
A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
An observational study of Ischemic Stroke, Acute, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- microbiome; metabolomics; proteomics
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital,Southern Medical University
Guangzhou, Guangdong, 510515
Jia Yin, M.D, 13802964883, jiajiayin@139.com
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- microbiome; metabolomics; proteomics
- Keywords
- Stroke recurrence, Post-stroke cognitive impairment, Post-stroke depression
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microbiome; metabolomics; proteomicsOther
post-stroke change of microbiome; metabolomics; proteomics
| Study group | Role | What they receive |
|---|---|---|
| modeling queue | The modeling queue is used to manage and prioritize tasks related to the development and training of models. Receives: Other: microbiome; metabolomics; proteomics | |
| validation queue | The validation queue is designed to handle tasks related to the evaluation and validation of models. Receives: Other: microbiome; metabolomics; proteomics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of new cardiovascular events and death
any stroke /TIA/ myocardial infarction/Vascular death
Measured: within 12 months after onset
Secondary outcomes (10)
Brain Injury Conditions
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.
Measured: 3, 12 months after ischemic stroke
Small Vessel Disease Burden
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.
Measured: 3, 12 months after ischemic stroke
Cerebrovascular Pathology
Clinical investigators evaluate cerebrovascular pathology according to head CT or MR, which including the signs of vascular stenosis, vascular dissection or collateral circulation compensation.
Measured: 3, 12 months after ischemic stroke
Modified Rankin Scale ( mRS ) score
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.
Measured: 7 day and 3, 12 months after ischemic stroke
National Institutes of Health Stroke Scale ( NIHSS ) score
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).
Measured: 7 day and 3, 12 months after ischemic stroke
Activity of Daily Living Scale ( ADL ) score
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.
Measured: 7 day and 3, 12 months after ischemic stroke
Mini-mental State Examination ( MMSE ) score
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.
Measured: 3, 12 months after ischemic stroke
Montreal Cognitive Assessment ( MOCA ) score
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.
Measured: 3, 12 months after ischemic stroke
Hamilton Depression Scale ( HAMD ) score
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).
Measured: 3, 12 months after ischemic stroke
Hamilton Anxiety Scale ( HAMA ) score
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).
Measured: 3, 12 months after ischemic stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start30 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584565
- Sponsor's protocol ID
- NFEC-2024-150
- Status last verified
- Sep 2024
- First submitted
- 26 Aug 2024
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study Based on Multi-omics Analysis to Predict the Early Prognosis and Recurrence Risk of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06584565
- Acronym / sponsor ID
- NFEC-2024-150
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Stroke recurrence, Post-stroke cognitive impairment, Post-stroke depression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| modeling queue | – | Other: microbiome; metabolomics; proteomicsThe modeling queue is used to manage and prioritize tasks related to the development and training of models. |
| validation queue | – | Other: microbiome; metabolomics; proteomicsThe validation queue is designed to handle tasks related to the evaluation and validation of models. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| microbiome; metabolomics; proteomicspost-stroke change of microbiome; metabolomics; proteomics | Other | modeling queue, validation queue |
Primary outcome
Incidence of new cardiovascular events and death
Time frame: within 12 months after onset
any stroke /TIA/ myocardial infarction/Vascular death
10 secondary outcomes
Brain Injury Conditions
Time frame: 3, 12 months after ischemic stroke
Small Vessel Disease Burden
Time frame: 3, 12 months after ischemic stroke
Cerebrovascular Pathology
Time frame: 3, 12 months after ischemic stroke
Modified Rankin Scale ( mRS ) score
Time frame: 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
Activity of Daily Living Scale ( ADL ) score
Time frame: 7 day and 3, 12 months after ischemic stroke
Mini-mental State Examination ( MMSE ) score
Time frame: 3, 12 months after ischemic stroke
Montreal Cognitive Assessment ( MOCA ) score
Time frame: 3, 12 months after ischemic stroke
Hamilton Depression Scale ( HAMD ) score
Time frame: 3, 12 months after ischemic stroke
Hamilton Anxiety Scale ( HAMA ) score
Time frame: 3, 12 months after ischemic stroke
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
Related trials for Ischemic Stroke, Acute
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruiting
Prehospital Response and Emergency Stroke Transport Optimisation
Acute Ischemic Stroke
Active, not recruiting
Efficacy and Safety of Endovascular Recanalization for Acute Basilar Artery Occlusion With Extended Time Window (ANGEL-BAO)
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingPhase 3
Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular Events
Acute Ischemic Stroke, Large Vessel Occlusion
RecruitingPhase 2
A Study to Evaluate the Intracranial Arterial Recanalization With Multiple Doses of LT3001 Drug Product in AIS Participant
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, Acute, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Yin, M.D (13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of new cardiovascular events and death (time frame: within 12 months after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024; AzTrials last refreshed its copy on 26 Oct 2026.