Acute Ischemic StrokeNCT06240468
Dynamic Changes in Human Microbiome Predict the Risk of Adverse Outcomes in Patients With Acute Ischemic Stroke: a Multicenter Prospective Cohort Study
An observational study of Acute Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial 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. To explore the characteristics of cross-regional disturbance of human microbiome in stroke patients; 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- not have
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2022to 30 Dec 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with ischemic stroke
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Hongwei Zhou, Professor, 18688489622, hzhou@smu.edu.cn
About this study
(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
- To explore the characteristics of cross-regional disturbance of human microbiome in stroke patients;
- To investigate the characteristics and rules of bacterial flora changes before and after recurrent apoplexy;
- Markers closely related to AIS prognosis and cognitive emotional complications were excavated by metagenomic, metabolic, peptide and imaging groups.
- To explore the relationship between serum markers of ultra early stage and prognosis.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- not have
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
not haveOther
not have
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: not have | |
| healthy person | health Receives: Other: not have |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: The follow-up period is one year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start10 Feb 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 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
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06240468
- Sponsor's protocol ID
- CALM2003
- Status last verified
- May 2023
- First submitted
- 11 Aug 2023
- Last updated
- 5 Feb 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 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Human Microbiome Predict the Risk of Adverse Outcomes in Patients With Acute Ischemic Stroke: a Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06240468
- Acronym / sponsor ID
- CALM2003
- Conditions
- Acute Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 5 Feb 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.
(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
- To explore the characteristics of cross-regional disturbance of human microbiome in stroke patients;
- To investigate the characteristics and rules of bacterial flora changes before and after recurrent apoplexy;
- Markers closely related to AIS prognosis and cognitive emotional complications were excavated by metagenomic, metabolic, peptide and imaging groups.
- To explore the relationship between serum markers of ultra early stage and prognosis.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AIS patient | – | Other: not haveAIS 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. |
| Cognitive/emotional subcohort | – | Other: not have(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. |
| healthy person | – | Other: not havehealth |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ischemic stroke
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| not havenot have | Other | AIS patient, Cognitive/emotional subcohort, healthy person |
Primary outcome
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;
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
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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.
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 Zhujiang Hospital 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 5 inclusion and 6 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 5 Feb 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mengxi Li (15013048680, 1135621389@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 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 5 Feb 2024.