Acute Ischemic StrokeNCT04978701
Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
An observational study of Acute Ischemic Stroke, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who met the eligibility criteria for acute ischemic stroke
Who may be able to join
- Meet the AIS diagnostic criteria;
- Age 18-80;
- Within 7 days of the onset;
- Signing the informed consent, providing relevant medical history and biological specimens.
Who cannot join
- mRS > score 2 before onset;
- Serious systemic diseases including malignant tumors;
- Hematological diseases and autoimmune diseases;
- ALT or AST > 2 times the upper limit of normal value or severe liver disease;
- Serum creatinine > 1.5 times the upper normal limit or severe nephropathy;
- History of alcoholism, drug abuse, and chemical poisoning (e.g. pesticide poisoning);
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- History of intestinal tumor, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital;
- Antibiotic use within 1 month before admission;
- Fece cannot be obtained within 4 days after admission.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology, NanFang Hospital, Southern Medical University
Guanzhou, Guangdong, 510515
Yin Jia, master's degree, +8613802964883, jiajiayin@139.com
Zhang Mingsi, +8613827003570, meens@qq.com
About this study
Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study
Read the detailed description
This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, microbiome, prognosis
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
modified Rankin Scale
An evaluation of neurological deficits
Measured: 3 months after the onset
National Institute of Health stroke scale
An evaluation of neurological deficits
Measured: 3 months after the onset
Major ischemic events
Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
Measured: within 3 months
Secondary outcomes (6)
modified Rankin Scale
An evaluation of neurological deficits
Measured: 6 months after the onset
National Institute of Health stroke scale
An evaluation of neurological deficits
Measured: 6 months after the onset
Major ischemic events
Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
Measured: within 6 months
modified Rankin Scale
An evaluation of neurological deficits
Measured: 12 months after the onset
National Institute of Health stroke scale
An evaluation of neurological deficits
Measured: 12 months after the onset
Major ischemic events
Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
Measured: within 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start1 Aug 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhujiang Hospital, Guangdong Yanling Hospital, Shenzhen University General Hospital, The First Hospital Of Qiqihar, Huzhou Central Hospital, Zhejiang Greentown Cardiovascular Hospital, People's Hospital of Leshan, Sichuan Province
- Responsible party
- Principal investigator, yinjia, Nanfang Hospital, Southern Medical University
- Investigators
- Yin Jia, Master, Principal investigator, Department of Neurology, NanFang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978701
- Sponsor's protocol ID
- NFEC-2021-220
- Status last verified
- Nov 2021
- First submitted
- 20 Jul 2021
- Last updated
- 12 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes of the Human Microbiome Predict the Risk of Poor Prognosis in Patients With Acute Ischemic Stroke: a Multi-center Study
- ClinicalTrials.gov ID
- NCT04978701
- Acronym / sponsor ID
- NFEC-2021-220
- Conditions
- Acute Ischemic Stroke
- Keywords
- acute ischemic stroke, microbiome, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Zhujiang Hospital, Guangdong Yanling Hospital, Shenzhen University General Hospital, The First Hospital Of Qiqihar, Huzhou Central Hospital, Zhejiang Greentown Cardiovascular Hospital, People's Hospital of Leshan, Sichuan Province
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 Jul 2021 (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.
Recent studies have found a close relationship between acute ischemic stroke(AIS) and gut microbiota, but whether the dynamic changes in human microbiome after stroke can predict poor prognosis of stroke remains unclear. Therefore, we planned to explore the predictive value of human microbiome and its metabolites in stroke prognosis through a multicenter cohort study
Detailed description
This study was designed as a prospective, observational, multicenter cohort study. 2000 patients with AIS will be enrolled continuously through multiple centers. Oral swabs, feces (the day after admission, 1 month, 3 months after the onset of disease) and blood samples (the day after admission, 3 months after the onset of disease) will be collected. After the onset of the disease (1 month, 3 months, 6 months and 12 months), outpatient/telephone follow-up will be conducted to evaluate the neurological function scores of the patients, and the recurrence of stroke and other cardio-cerebrovascular events will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who met the eligibility criteria for acute ischemic stroke
Key inclusion criteria (4 listed)
- Meet the AIS diagnostic criteria;
- Age 18-80;
- Within 7 days of the onset;
- Signing the informed consent, providing relevant medical history and biological specimens.
Key exclusion criteria (9 listed)
- mRS > score 2 before onset;
- Serious systemic diseases including malignant tumors;
- Hematological diseases and autoimmune diseases;
- ALT or AST > 2 times the upper limit of normal value or severe liver disease;
- Serum creatinine > 1.5 times the upper normal limit or severe nephropathy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
modified Rankin Scale
Time frame: 3 months after the onset
An evaluation of neurological deficits
National Institute of Health stroke scale
Time frame: 3 months after the onset
An evaluation of neurological deficits
Major ischemic events
Time frame: within 3 months
Major ischemic event is defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event.
6 secondary outcomes
modified Rankin Scale
Time frame: 6 months after the onset
National Institute of Health stroke scale
Time frame: 6 months after the onset
Major ischemic events
Time frame: within 6 months
modified Rankin Scale
Time frame: 12 months after the onset
National Institute of Health stroke scale
Time frame: 12 months after the onset
Major ischemic events
Time frame: within 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2021.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Yin Jia, Master principal investigator
Department of Neurology, NanFang Hospital, Southern Medical University
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 Acute Ischemic Stroke, 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: status not confirmed, as of the sponsor's last update on 12 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yin Jia, Master (+86 13802964883, jiajiayin@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
modified Rankin Scale (time frame: 3 months after the onset). The study lists 3 primary outcomes in all. 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 12 Nov 2021.