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Cerebrospinal Fluid Mitochondrial Biomarkers in Ischemic Stroke and Alzheimer Disease

perjantai 4. syyskuuta 2026 päivittänyt: Ji Xunming,MD,PhD, Capital Medical University

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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Havainnollistava

Ilmoittautuminen (Todellinen)

40

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Kiina
    • None Selected
      • Beijing, None Selected, Kiina, 100053
        • Xuanwu Hospital

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen
  • Vanhempi Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Näytteenottomenetelmä

Ei-todennäköisyysnäyte

Tutkimusväestö

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.

Kuvaus

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

Kohortit ja interventiot

Ryhmä/Kohortti
Interventio / Hoito
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.
Diagnostinen testi: Cerebrospinal Fluid Flow Cytometry
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.
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.
Diagnostinen testi: Cerebrospinal Fluid Flow Cytometry
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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Aikaikkuna: 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.
Day 90 after stroke onset

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Association Between Cerebrospinal Fluid MitoTracker Median Fluorescence Intensity and 90-Day Modified Rankin Scale Score in Patients With Ischemic Stroke
Aikaikkuna: Day 90 after stroke onset
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.
Day 90 after stroke onset
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Baseline National Institutes of Health Stroke Scale Score
Aikaikkuna: Baseline, within 24 hours after hospital admission
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.
Baseline, within 24 hours after hospital admission
Association Between Cerebrospinal Fluid MitoTracker-Positive Event Count and Discharge National Institutes of Health Stroke Scale Score
Aikaikkuna: At hospital discharge, up to 30 days after hospital admission
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.
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
Aikaikkuna: From baseline within 24 hours after hospital admission to hospital discharge, up to 30 days after hospital admission
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.
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
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
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.
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
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
Cerebrospinal fluid (CSF) MitoTracker-positive event count will be compared between patients with ischemic stroke and Alzheimer disease controls at baseline.
Baseline, at the time of diagnostic lumbar puncture

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 45
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
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.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 41
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
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.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Cluster of Differentiation 24
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
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.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing von Willebrand Factor
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
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.
Baseline, at the time of diagnostic lumbar puncture
Percentage of Cerebrospinal Fluid MitoTracker-Positive Events Expressing Excitatory Amino Acid Transporter 1
Aikaikkuna: Baseline, at the time of diagnostic lumbar puncture
The percentage of cerebrospinal fluid (CSF) MitoTracker-positive events expressing excitatory amino acid transporter 1 (EAAT1) will be measured by flow cytometry to characterize astrocytic or glial-associated mitochondrial events.
Baseline, at the time of diagnostic lumbar puncture

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Capital Medical University

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Sunnuntai 1. maaliskuuta 2026

Ensisijainen valmistuminen (Todellinen)

Sunnuntai 31. toukokuuta 2026

Opintojen valmistuminen (Todellinen)

Sunnuntai 30. elokuuta 2026

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 15. toukokuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 15. toukokuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Perjantai 22. toukokuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 9. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 4. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • CSF-MITO

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

The study is proceeding.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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