RecruitingNCT07600996

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

Sponsor

Capital Medical University

Enrollment

40 participants

Start Date

Mar 1, 2026

Study Type

OBSERVATIONAL

Conditions

Ischemic Stroke Alzheimer Disease (AD)

Summary

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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.

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Interventions

DIAGNOSTIC_TESTCerebrospinal 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.