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NCT Number: NCT07471061

Acute Ischemic Stroke Involves Significant Inflammatory Response. This Prospective Cohort Study Evaluates the Predictive Value of Monocyte-, Neutrophil-, and Leukocyte-to-albumin Ratios for Stroke Severity and Functional Outcome Using NIHSS at Admission and Modified Rankin Scale During Follow-up.

Acute Ischemic Stroke is a leading cause of mortality and long-term disability worldwide. Increasing evidence suggests that systemic inflammation plays a significant role in the pathophysiology and progression of ischemic brain injury. Recently, several inflammatory biomarkers derived from routine laboratory tests have been investigated as potential predictors of stroke severity and clinical outcome.

This prospective cohort study aims to evaluate the predictive utility of the monocyte-to-albumin ratio, neutrophil-to-albumin ratio, and total leukocytic count-to-albumin ratio in patients with acute ischemic stroke. These indices combine inflammatory cell counts with serum albumin levels and may reflect both systemic inflammatory status and nutritional condition.

Stroke severity will be assessed at admission using the NIH Stroke Scale, while functional outcome will be evaluated during follow-up using the Modified Rankin Scale. The study aims to determine whether these simple and readily available biomarkers can serve as reliable predictors of stroke severity and prognosis in patients with acute ischemic stroke.

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Key information

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥ 18 years old) admitted with a diagnosis of acute ischemic stroke confirmed by brain imaging (CT or MRI).
  • Admission within a defined time window from stroke onset (e.g., within 48 hours) to capture acute inflammatory response.
  • Availability of complete blood count (CBC) with differential and serum -albumin levels at admission.
  • Informed consent obtained from the patient or their legal representative.

Exclusion criteria

  • Patients with hemorrhagic stroke or transient ischemic attack (TIA).
  • Patients with previous history of ischemic stroke.
  • Patients who accepted intravenous thrombolysis (IV tPA) and or mechanical thrombectomy.
  • Pre-existing inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease) that could influence monocyte count or albumin levels.
  • Active infections (bacterial, viral, fungal) at admission.
  • Severe liver or kidney disease affecting albumin synthesis or catabolism.
  • Hematological disorders affecting white blood cell counts. ⚫ Patients on immunosuppressive therapy or corticosteroids.
  • Patients with known malignancy
  • Lack of complete blood count (CBC) with differential and serum albumin levels at admission.
  • Patients who received blood transfusions before blood sampling.
  • Patients with other acute severe medical conditions that significantly impact inflammatory markers (e.g., sepsis, major trauma).

Treatment and study plan

Primary outcomes

  1. Stroke severity at admission

    Time frame: At admission

    Stroke severity will be assessed using the National Institutes of Health Stroke Scale (NIHSS) at hospital admission. The total score ranges from 0 to 42, with higher scores indicating more severe neurological deficit.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Mounir, MSc candidate

CONTACT

[email protected]

201159874599

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Predictive Utility of Monocyte-to-Albumin Neutrophil to Albumin and Total Leukocytic Count-to-Albumin Ratios in Ischemic Stroke. A Cohort Study

Acronym: ALARMS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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