NCT07471061

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress41%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 10, 2026

Last Update Submit

March 13, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Stroke severity 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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Mohamed Mounir, MSc candidate

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc Candidate, Department of Neurology and PsychologicalMedicine, Faculty of Medicine Sohag University

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03