Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

15 maja 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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 studiów

Obserwacyjny

Zapisy (Szacowany)

40

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Chiny
    • None Selected
      • Beijing, None Selected, Chiny, 100053
        • Rekrutacyjny
        • Xuanwu Hospital
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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 diagnostyczny: 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 diagnostyczny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Association Between Cerebrospinal Fluid Mitochondrial Content and 90-Day Modified Rankin Scale Score in Ischemic Stroke
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Association Between Cerebrospinal Fluid Mitochondrial Content and Admission NIHSS Score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Capital Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

1 marca 2026

Zakończenie podstawowe (Szacowany)

31 sierpnia 2026

Ukończenie studiów (Szacowany)

30 listopada 2026

Daty rejestracji na studia

Pierwszy przesłany

15 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

15 maja 2026

Pierwszy wysłany (Rzeczywisty)

22 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 maja 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 maja 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • CSF-MITO

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

The study is proceeding.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Udar niedokrwienny

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Armenia

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj