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. (ALARMS)

March 13, 2026 updated by: Mohamed Mounir Abbas, Sohag University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

This study will include adult patients (≥18 years) diagnosed with acute ischemic stroke, confirmed clinically and by neuroimaging, who present to the hospital within 24 hours of symptom onset. Patients with hemorrhagic stroke, active infection, chronic inflammatory diseases, malignancy, severe liver or kidney disease, or those receiving immunosuppressive therapy will be excluded.

All participants will undergo routine blood tests to calculate monocyte-to-albumin, neutrophil-to-albumin, and total leukocyte-to-albumin ratios. Stroke severity will be assessed at admission using the NIH Stroke Scale, and functional outcome will be evaluated during follow-up using the Modified Rankin Scale.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--25-12-14MS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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