Acute Ischemic Stroke (AIS)ALARMSNCT07471061
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.
An observational study of Acute Ischemic Stroke (AIS), run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke (AIS)
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 1 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Acute Ischemic Stroke (AIS)
- Medical subject headings
- Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke (AIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mounir Abbas, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471061
- Sponsor's protocol ID
- Soh-Med--25-12-14MS
- Acronym
- ALARMS
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Utility of Monocyte-to-Albumin Neutrophil to Albumin and Total Leukocytic Count-to-Albumin Ratios in Ischemic Stroke. A Cohort Study
- ClinicalTrials.gov ID
- NCT07471061
- Acronym / sponsor ID
- ALARMS / Soh-Med--25-12-14MS
- Conditions
- Acute Ischemic Stroke (AIS)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke (AIS), run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mounir, MSc candidate (201159874599, mohamed.mounir886@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stroke severity at admission (time frame: At admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.