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.
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Xi Chen, MD/PhD
- Telefonní číslo: 8617600104266
- E-mail: chenxi00cx@126.com
Studijní místa
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None Selected
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Beijing, None Selected, Čína, 100053
- Nábor
- Xuanwu Hospital
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Kontakt:
- Xi Chen
- Telefonní číslo: +86 17600104266
- E-mail: chenxi00cx@126.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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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.
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Association Between Cerebrospinal Fluid Mitochondrial Content and 90-Day Modified Rankin Scale Score in Ischemic Stroke
Časové okno: From baseline cerebrospinal fluid collection to 90 days after stroke onset or hospital admission
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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.
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From baseline cerebrospinal fluid collection to 90 days after stroke onset or hospital admission
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Association Between Cerebrospinal Fluid Mitochondrial Content and Admission NIHSS Score
Časové okno: At hospital admission or baseline clinical assessment
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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.
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At hospital admission or baseline clinical assessment
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Association Between Cerebrospinal Fluid Mitochondrial Content and Discharge NIHSS Score
Časové okno: At hospital discharge, up to 7 days after admission
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The association between cerebrospinal fluid mitochondrial content and neurological deficit at discharge will be assessed using the NIHSS score recorded at hospital discharge.
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At hospital discharge, up to 7 days after admission
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Cerebrospinal Fluid Mitochondrial Membrane Potential Measured by JC-1
Časové okno: At baseline cerebrospinal fluid collection
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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.
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At baseline cerebrospinal fluid collection
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Comparison of Cerebrospinal Fluid Mitochondrial Biomarkers Between Ischemic Stroke and Alzheimer Disease Controls
Časové okno: At baseline cerebrospinal fluid collection
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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.
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At baseline cerebrospinal fluid collection
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Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
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Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- CSF-MITO
Plán pro data jednotlivých účastníků (IPD)
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