Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCapital Medical University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older. Patients treated at Xuanwu Hospital, Capital Medical University between March 2026 and May 2026.
Disqualifiers
Lumbar puncture performed solely for research purposes rather than clinical indication.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cerebrospinal Fluid Flow Cytometry
Diagnostic testResidual 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Ischemic Stroke Cohort1 intervention
Group B: Alzheimer Disease Control Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Day 90 after stroke onsetSecondary outcomes
1
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.
Time frame
Day 90 after stroke onset2
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.
Time frame
Baseline, within 24 hours after hospital admission3
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.
Time frame
At hospital discharge, up to 30 days after hospital admission4
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.
Time frame
From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admissionOther outcomes
1
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 45
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 45 (CD45) will be measured by flow cytometry to characterize leukocyte-associated mitochondrial events.
Time frame
Baseline, at the time of diagnostic lumbar puncture2
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 41
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 41 (CD41) will be measured by flow cytometry to characterize platelet-associated mitochondrial events.
Time frame
Baseline, at the time of diagnostic lumbar puncture3
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 24
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing cluster of differentiation 24 (CD24) will be measured by flow cytometry to characterize CD24-positive mitochondrial events.
Time frame
Baseline, at the time of diagnostic lumbar puncture4
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing von Willebrand Factor
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing von Willebrand factor (vWF) will be measured by flow cytometry to characterize endothelial-associated mitochondrial events.
Time frame
Baseline, at the time of diagnostic lumbar punctureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Capital Medical University
Lead sponsor
Xuanwu Hospital, Beijing
Sponsor institution
Source ClinicalTrials.gov