Ischemic StrokeNCT07600996
Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease
An observational study of Ischemic Stroke and Alzheimer Disease (AD), run by Capital Medical University at 1 site in China.
Trial summary
This prospective observational study aims to investigate cerebrospinal fluid mitochondrial biomarkers in patients with ischemic stroke and Alzheimer disease controls who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Alzheimer Disease (AD)
- What is being tested?
- Cerebrospinal Fluid Flow Cytometry
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 30 Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026 who are diagnosed with ischemic stroke or Alzheimer disease and require diagnostic lumbar puncture for clinical indications. Only patients with available residual cerebrospinal fluid after completion of routine clinical testing will be included.
Who may be able to join
- Age 18 years or older. Patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026.
- Diagnosis of ischemic stroke or Alzheimer disease according to standard clinical diagnostic criteria.
- Diagnostic lumbar puncture performed for clinical indications as part of routine medical care.
- Availability of residual cerebrospinal fluid after completion of clinically required testing.
- Ability to provide written informed consent, or availability of a legally authorized representative to provide consent when appropriate.
- For ischemic stroke patients, availability of baseline neurological assessment and planned follow-up for 90-day modified Rankin Scale assessment.
Who cannot join
- Lumbar puncture performed solely for research purposes rather than clinical indication.
- Insufficient residual cerebrospinal fluid volume for research flow cytometry analysis.
- Grossly bloody or severely contaminated cerebrospinal fluid sample that precludes reliable flow cytometry analysis.
- Known central nervous system infection, malignant meningitis, or other inflammatory or neoplastic condition that, in the investigator's judgment, may substantially confound cerebrospinal fluid mitochondrial measurements.
- Inability to obtain informed consent from the participant or legally authorized representative.
- Missing key clinical outcome data, including admission NIHSS, discharge NIHSS, or planned 90-day mRS follow-up for ischemic stroke participants.
- Any condition judged by the investigator to make the participant unsuitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Observational Study of Cerebrospinal Fluid Mitochondrial Biomarkers Measured by Flow Cytometry in Patients With Ischemic Stroke and Alzheimer Disease Controls
This prospective observational study aims to investigate cerebrospinal fluid mitochondrial biomarkers in patients with ischemic stroke and Alzheimer disease controls who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University.
Residual cerebrospinal fluid samples will be analyzed by flow cytometry to quantify mitochondrial content, mitochondrial membrane potential, and cellular or vesicular source-related markers. The flow cytometry panel will include MitoTracker, JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1.
In patients with ischemic stroke, the study will further examine whether cerebrospinal fluid mitochondrial measurements are associated with neurological severity and functional outcomes, including admission and discharge NIHSS scores and the 90-day modified Rankin Scale score. Alzheimer disease patients undergoing diagnostic lumbar puncture will serve as disease controls for biomarker comparison.
Read the detailed description
Mitochondrial dysfunction is closely associated with ischemic brain injury, but the clinical relevance of extracellular or cell-associated mitochondrial signals in the cerebrospinal fluid of patients with ischemic stroke remains insufficiently characterized. Cerebrospinal fluid may provide a biologically informative compartment for assessing mitochondrial injury, mitochondrial membrane potential, and potential cellular sources of mitochondrial signals in neurological diseases.
This is a single-center, prospective, observational study conducted at Xuanwu Hospital, Capital Medical University. The study will enroll patients with ischemic stroke or Alzheimer disease who require diagnostic lumbar puncture as part of routine clinical evaluation between March 2026 and May 2026. No lumbar puncture will be performed solely for research purposes. After completion of clinically required testing, available residual cerebrospinal fluid will be collected for research flow cytometry analysis.
Flow cytometry will be used to evaluate cerebrospinal fluid mitochondrial content and related phenotypic features. MitoTracker will be used to detect mitochondrial signal, JC-1 will be used to assess mitochondrial membrane potential, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1 will be used to characterize potential leukocyte-associated, platelet-associated, neuronal/extracellular vesicle-associated, endothelial-associated, and astrocytic/glial-associated components.
The primary analysis will focus on patients with ischemic stroke and will evaluate the association between cerebrospinal fluid mitochondrial content and 90-day functional outcome measured by the modified Rankin Scale. Secondary analyses will examine associations between cerebrospinal fluid mitochondrial measurements and admission NIHSS, discharge NIHSS, and changes in NIHSS during hospitalization. Exploratory analyses will compare cerebrospinal fluid mitochondrial and membrane-marker profiles between ischemic stroke patients and Alzheimer disease controls.
- Conditions
- Ischemic Stroke, Alzheimer Disease (AD)
- Being tested
- Cerebrospinal Fluid Flow Cytometry
- Keywords
- Cerebrospinal fluid, Mitochondria, MitoTracker, NIHSS, Stroke outcome
- Medical subject headings
- Ischemic Stroke, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebrospinal Fluid Flow CytometryDiagnostic test
Residual cerebrospinal fluid obtained during clinically indicated diagnostic lumbar puncture will be analyzed by flow cytometry. The assay will measure mitochondrial signal using MitoTracker, mitochondrial membrane potential using JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1. The study does not assign participants to any treatment or diagnostic procedure beyond routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke Cohort | Patients diagnosed with ischemic stroke who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by flow cytometry to assess mitochondrial content, mitochondrial membrane potential, and membrane-associated markers. Clinical outcomes will include admission NIHSS, discharge NIHSS, and 90-day modified Rankin Scale score. Receives: Diagnostic Test: Cerebrospinal Fluid Flow Cytometry | |
| Alzheimer Disease Control Cohort | Patients diagnosed with Alzheimer disease who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by the same flow cytometry panel and used as a disease control group for comparison of cerebrospinal fluid mitochondrial and membrane-marker profiles. Receives: Diagnostic Test: Cerebrospinal Fluid Flow Cytometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
The primary outcome is the association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and functional outcome assessed by the modified Rankin Scale (mRS) on Day 90 after stroke onset. The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
Measured: Day 90 after stroke onset
Secondary outcomes (6)
Association Between Cerebrospinal Fluid MitoTracker Median Fluorescence Intensity and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
The association between cerebrospinal fluid (CSF) MitoTracker median fluorescence intensity measured at baseline and 90-day modified Rankin Scale (mRS) score will be assessed in patients with ischemic stroke.
Measured: Day 90 after stroke onset
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Baseline National Institutes of Health Stroke Scale Score
The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and neurological deficit severity will be assessed using the National Institutes of Health Stroke Scale (NIHSS) score obtained within 24 hours after hospital admission. Higher NIHSS scores indicate more severe neurological impairment.
Measured: Baseline, within 24 hours after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Discharge National Institutes of Health Stroke Scale Score
The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and neurological deficit severity at discharge will be assessed using the National Institutes of Health Stroke Scale (NIHSS) score recorded at hospital discharge.
Measured: At hospital discharge, up to 30 days after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Change in National Institutes of Health Stroke Scale Score During Hospitalization
Change in National Institutes of Health Stroke Scale (NIHSS) score will be calculated as the discharge NIHSS score minus the baseline NIHSS score obtained within 24 hours after hospital admission. The association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and change in NIHSS score during hospitalization will be evaluated.
Measured: From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admission
Cerebrospinal Fluid JC-1 Red-to-Green Fluorescence Ratio
Mitochondrial membrane potential in cerebrospinal fluid (CSF)-associated mitochondrial events will be assessed using JC-1 dye by flow cytometry. The JC-1 red-to-green fluorescence ratio will be used as a measure of mitochondrial polarization status.
Measured: Baseline, at the time of diagnostic lumbar puncture
Difference in Cerebrospinal Fluid MitoTracker-Positive Event Count Between Patients With Ischemic Stroke and Alzheimer Disease Controls
Cerebrospinal fluid (CSF) MitoTracker-positive event count will be compared between patients with ischemic stroke and Alzheimer disease controls at baseline.
Measured: Baseline, at the time of diagnostic lumbar puncture
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Mar 2026
- Primary completion31 May 2026
- Study completion30 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600996
- Sponsor's protocol ID
- CSF-MITO
- Status last verified
- Sep 2026
- First submitted
- 15 May 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No: The study is proceeding.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Cerebrospinal Fluid Mitochondrial Biomarkers Measured by Flow Cytometry in Patients With Ischemic Stroke and Alzheimer Disease Controls
- ClinicalTrials.gov ID
- NCT07600996
- Acronym / sponsor ID
- CSF-MITO
- Conditions
- Ischemic Stroke, Alzheimer Disease (AD)
- Keywords
- Cerebrospinal fluid, Mitochondria, MitoTracker, NIHSS, Stroke outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 30 Aug 2026 (actual)
- First posted
- 22 May 2026 (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.
This prospective observational study aims to investigate cerebrospinal fluid mitochondrial biomarkers in patients with ischemic stroke and Alzheimer disease controls who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University.
Residual cerebrospinal fluid samples will be analyzed by flow cytometry to quantify mitochondrial content, mitochondrial membrane potential, and cellular or vesicular source-related markers. The flow cytometry panel will include MitoTracker, JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1.
In patients with ischemic stroke, the study will further examine whether cerebrospinal fluid mitochondrial measurements are associated with neurological severity and functional outcomes, including admission and discharge NIHSS scores and the 90-day modified Rankin Scale score. Alzheimer disease patients undergoing diagnostic lumbar puncture will serve as disease controls for biomarker comparison.
Detailed description
Mitochondrial dysfunction is closely associated with ischemic brain injury, but the clinical relevance of extracellular or cell-associated mitochondrial signals in the cerebrospinal fluid of patients with ischemic stroke remains insufficiently characterized. Cerebrospinal fluid may provide a biologically informative compartment for assessing mitochondrial injury, mitochondrial membrane potential, and potential cellular sources of mitochondrial signals in neurological diseases.
This is a single-center, prospective, observational study conducted at Xuanwu Hospital, Capital Medical University. The study will enroll patients with ischemic stroke or Alzheimer disease who require diagnostic lumbar puncture as part of routine clinical evaluation between March 2026 and May 2026. No lumbar puncture will be performed solely for research purposes. After completion of clinically required testing, available residual cerebrospinal fluid will be collected for research flow cytometry analysis.
Flow cytometry will be used to evaluate cerebrospinal fluid mitochondrial content and related phenotypic features. MitoTracker will be used to detect mitochondrial signal, JC-1 will be used to assess mitochondrial membrane potential, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1 will be used to characterize potential leukocyte-associated, platelet-associated, neuronal/extracellular vesicle-associated, endothelial-associated, and astrocytic/glial-associated components.
The primary analysis will focus on patients with ischemic stroke and will evaluate the association between cerebrospinal fluid mitochondrial content and 90-day functional outcome measured by the modified Rankin Scale. Secondary analyses will examine associations between cerebrospinal fluid mitochondrial measurements and admission NIHSS, discharge NIHSS, and changes in NIHSS during hospitalization. Exploratory analyses will compare cerebrospinal fluid mitochondrial and membrane-marker profiles between ischemic stroke patients and Alzheimer disease controls.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke Cohort | – | Diagnostic Test: Cerebrospinal Fluid Flow CytometryPatients diagnosed with ischemic stroke who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by flow cytometry to assess mitochondrial content, mitochondrial membrane potential, and membrane-associated markers. Clinical outcomes will include admission NIHSS, discharge NIHSS, and 90-day modified Rankin Scale score. |
| Alzheimer Disease Control Cohort | – | Diagnostic Test: Cerebrospinal Fluid Flow CytometryPatients diagnosed with Alzheimer disease who undergo diagnostic lumbar puncture for clinical indications at Xuanwu Hospital, Capital Medical University. Residual cerebrospinal fluid will be analyzed by the same flow cytometry panel and used as a disease control group for comparison of cerebrospinal fluid mitochondrial and membrane-marker profiles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026 who are diagnosed with ischemic stroke or Alzheimer disease and require diagnostic lumbar puncture for clinical indications. Only patients with available residual cerebrospinal fluid after completion of routine clinical testing will be included.
Key inclusion criteria (6 listed)
- Age 18 years or older. Patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026.
- Diagnosis of ischemic stroke or Alzheimer disease according to standard clinical diagnostic criteria.
- Diagnostic lumbar puncture performed for clinical indications as part of routine medical care.
- Availability of residual cerebrospinal fluid after completion of clinically required testing.
- Ability to provide written informed consent, or availability of a legally authorized representative to provide consent when appropriate.
Key exclusion criteria (7 listed)
- Lumbar puncture performed solely for research purposes rather than clinical indication.
- Insufficient residual cerebrospinal fluid volume for research flow cytometry analysis.
- Grossly bloody or severely contaminated cerebrospinal fluid sample that precludes reliable flow cytometry analysis.
- Known central nervous system infection, malignant meningitis, or other inflammatory or neoplastic condition that, in the investigator's judgment, may substantially confound cerebrospinal fluid mitochondrial measurements.
- Inability to obtain informed consent from the participant or legally authorized representative.
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 |
|---|---|---|
| Cerebrospinal Fluid Flow CytometryResidual cerebrospinal fluid obtained during clinically indicated diagnostic lumbar puncture will be analyzed by flow cytometry. The assay will measure mitochondrial signal using MitoTracker, mitochondrial membrane potential using JC-1, and membrane-associated markers including CD45, CD41, CD24, vWF, and EAAT1. The study does not assign participants to any treatment or diagnostic procedure beyond routine clinical care. | Diagnostic test | Alzheimer Disease Control Cohort, Ischemic Stroke Cohort |
Primary outcome
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Time frame: Day 90 after stroke onset
The primary outcome is the association between cerebrospinal fluid (CSF) MitoTracker-positive event count measured at baseline and functional outcome assessed by the modified Rankin Scale (mRS) on Day 90 after stroke onset. The mRS ranges from 0 to 6, with higher scores indicating greater disability or death.
6 secondary outcomes
Association Between Cerebrospinal Fluid MitoTracker Median Fluorescence Intensity and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Time frame: Day 90 after stroke onset
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Baseline National Institutes of Health Stroke Scale Score
Time frame: Baseline, within 24 hours after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Discharge National Institutes of Health Stroke Scale Score
Time frame: At hospital discharge, up to 30 days after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Change in National Institutes of Health Stroke Scale Score During Hospitalization
Time frame: From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admission
Cerebrospinal Fluid JC-1 Red-to-Green Fluorescence Ratio
Time frame: Baseline, at the time of diagnostic lumbar puncture
Difference in Cerebrospinal Fluid MitoTracker-Positive Event Count Between Patients With Ischemic Stroke and Alzheimer Disease Controls
Time frame: Baseline, at the time of diagnostic lumbar puncture
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No. The study is proceeding.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Alzheimer Disease (AD), run by Capital 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 9 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke (time frame: Day 90 after stroke 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 9 Sep 2026.