Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 8:53 PM
Study NCT ID:
NCT07471061
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-17
First Post:
2026-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-13', 'studyFirstSubmitDate': '2026-03-10', 'studyFirstSubmitQcDate': '2026-03-10', 'lastUpdatePostDateStruct': {'date': '2026-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke severity at admission', 'timeFrame': 'At admission', 'description': '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.'}]}, 'conditionsModule': {'conditions': ['Acute Ischemic Stroke (AIS)']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.\n\nStroke 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nAll 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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (≥ 18 years old) admitted with a diagnosis of acute ischemic stroke confirmed by brain imaging (CT or MRI).\n* Admission within a defined time window from stroke onset (e.g., within 48 hours) to capture acute inflammatory response.\n* Availability of complete blood count (CBC) with differential and serum -albumin levels at admission.\n* Informed consent obtained from the patient or their legal representative.\n\nExclusion Criteria:\n\n* Patients with hemorrhagic stroke or transient ischemic attack (TIA).\n* Patients with previous history of ischemic stroke.\n* Patients who accepted intravenous thrombolysis (IV tPA) and or mechanical thrombectomy.\n* Pre-existing inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease) that could influence monocyte count or albumin levels.\n* Active infections (bacterial, viral, fungal) at admission.\n* Severe liver or kidney disease affecting albumin synthesis or catabolism.\n* Hematological disorders affecting white blood cell counts. ⚫ Patients on immunosuppressive therapy or corticosteroids.\n* Patients with known malignancy\n* Lack of complete blood count (CBC) with differential and serum albumin levels at admission.\n* Patients who received blood transfusions before blood sampling.\n* Patients with other acute severe medical conditions that significantly impact inflammatory markers (e.g., sepsis, major trauma).'}, 'identificationModule': {'nctId': 'NCT07471061', 'acronym': 'ALARMS', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Predictive Utility of Monocyte-to-Albumin Neutrophil to Albumin and Total Leukocytic Count-to-Albumin Ratios in Ischemic Stroke. A Cohort Study', 'orgStudyIdInfo': {'id': 'Soh-Med--25-12-14MS'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Mounir, MSc candidate', 'role': 'CONTACT', 'email': 'mohamed.mounir886@gmail.com', 'phone': '201159874599'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc Candidate, Department of Neurology and PsychologicalMedicine, Faculty of Medicine Sohag University', 'investigatorFullName': 'Mohamed Mounir Abbas', 'investigatorAffiliation': 'Sohag University'}}}}