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A Prospective Observational Study of Cerebrospinal Fluid Mitochondrial Biomarkers Measured by Flow Cytometry in Patients With Ischemic Stroke and Alzheimer Disease Controls

15 maggio 2026 aggiornato da: Ji Xunming,MD,PhD, Capital Medical University

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

40

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • None Selected
      • Beijing, None Selected, Cina, 100053
        • Reclutamento
        • Xuanwu Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

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.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Test diagnostico: 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.
Test diagnostico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association Between Cerebrospinal Fluid Mitochondrial Content and 90-Day Modified Rankin Scale Score in Ischemic Stroke
Lasso di tempo: From baseline cerebrospinal fluid collection to 90 days after stroke onset or hospital admission
The primary outcome is the association between cerebrospinal fluid mitochondrial content, measured by flow cytometry using MitoTracker-positive events or MitoTracker fluorescence intensity, and functional outcome at 90 days assessed by the modified Rankin Scale. The modified Rankin Scale ranges from 0 to 6, with higher scores indicating greater disability or death.
From baseline cerebrospinal fluid collection to 90 days after stroke onset or hospital admission

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Association Between Cerebrospinal Fluid Mitochondrial Content and Admission NIHSS Score
Lasso di tempo: At hospital admission or baseline clinical assessment
The association between cerebrospinal fluid mitochondrial content and baseline neurological deficit severity will be assessed using the National Institutes of Health Stroke Scale. Higher NIHSS scores indicate more severe neurological impairment.
At hospital admission or baseline clinical assessment
Association Between Cerebrospinal Fluid Mitochondrial Content and Discharge NIHSS Score
Lasso di tempo: At hospital discharge, up to 7 days after admission
The association between cerebrospinal fluid mitochondrial content and neurological deficit at discharge will be assessed using the NIHSS score recorded at hospital discharge.
At hospital discharge, up to 7 days after admission
Cerebrospinal Fluid Mitochondrial Membrane Potential Measured by JC-1
Lasso di tempo: At baseline cerebrospinal fluid collection
Mitochondrial membrane potential in cerebrospinal fluid-associated mitochondrial events will be assessed by JC-1 flow cytometry. JC-1 fluorescence parameters will be used to characterize mitochondrial polarization status.
At baseline cerebrospinal fluid collection
Comparison of Cerebrospinal Fluid Mitochondrial Biomarkers Between Ischemic Stroke and Alzheimer Disease Controls
Lasso di tempo: At baseline cerebrospinal fluid collection
Cerebrospinal fluid mitochondrial content, JC-1-related mitochondrial membrane potential measures, and membrane-associated marker profiles will be compared between ischemic stroke patients and Alzheimer disease controls.
At baseline cerebrospinal fluid collection

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Capital Medical University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 marzo 2026

Completamento primario (Stimato)

31 agosto 2026

Completamento dello studio (Stimato)

30 novembre 2026

Date di iscrizione allo studio

Primo inviato

15 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2026

Primo Inserito (Effettivo)

22 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CSF-MITO

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

The study is proceeding.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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