Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-30 @ 6:16 PM
Study NCT ID:
NCT05750303
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-20', 'lastUpdatePostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes from baseline in IGF-1 level in plasma at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 level in plasma - unit measure: ng/mL.'}, {'measure': 'changes from baseline IGF-1 expression in whole blood sample at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'IGF-1 is a protein involved in neuroplasticity and angiogenesis processes. IGF-1 mRNA gene expression is presented as -ΔCt'}, {'measure': 'changes from baseline in VEGF level in plasma at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF level in plasma - unit measure: pg/mL.'}, {'measure': 'changes from baseline in VEGF expression in whole blood sample at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'VEGF is a protein involved in neuroplasticity and angiogenesis processes. VEGF mRNA gene expression is presented as -ΔCt'}, {'measure': 'changes from baseline in MMP-9 level in plasma at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 level in plasma - unit of measure: pg/mL.'}, {'measure': 'changes from baseline in MMP-9 expression in whole blood sample at 3 week of rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'MMP-9 is a protein involved in neuroplasticity and angiogenesis processes. MMP-9 mRNA gene expression is presented as -ΔCt'}, {'measure': 'changes form baseline in Mini Mental State Examination (MMSE) scale at 3-week rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'Mini Mental State Examination is effective, screening tool for cognitive impairment, the maximum score for the MMSE is 30, a cut-off score of 23/24 (or below) indicates dementia, a score of 25 or higher is classed as normal'}, {'measure': 'changes form baseline in The Geriatric Depression Scale (GDS) at 3-week rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'The Geriatric Depression Scale is self-reported validated measure of depression in older adults, consists of 15 questions, users respond in a "Yes/No" format, scores 0-4 are considered normal, more than 5 indicate depression: 5-8 mild, 9-11 moderate and 12-15 severe depressive symptoms'}, {'measure': 'changes form baseline in Barthel index scale at 3-week rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'Barthel index is a scale used to measure performance in activities of daily living, the 10 items including the Barthel Index pay attention to self-care and mobility. Total possible scores range from 0 - 20, with lower scores indicating increased disability, a score of 17 represents normal ability.'}, {'measure': 'changes form baseline in National Institutes of Health Stroke Scale (NIHSS) scale at 3-week rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'National Institutes of Health Stroke Scale is a tool used to objectively quantify the impairment caused by stroke,total score ranging from 0 to 42 and the higher the score, the more severe the stroke'}, {'measure': 'changes form baseline in Modified Rankin Scale (MRS) at 3-week rehabilitation', 'timeFrame': 'baseline and 3 weeks later', 'description': 'Modified Rankin Scale measures degree of disability after stroke, ranges from grade 0 indicating a lack of symptoms to grade 6 indicating dead'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stroke', 'recovery', 'biomarker', 'rehabilitation', 'VEGF', 'IGF-1', 'MMP-9'], 'conditions': ['Ischemic Stroke']}, 'descriptionModule': {'briefSummary': 'Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation.', 'detailedDescription': 'Despite increasingly effective early treatment strategies for ischemic stroke, post-stroke recovery is often incomplete and depend on spontaneous and therapeutic-induced processes related to neuroplasticity, angiogenesis and reperfusion. These processes are regulated by growth factors, neurotrophines, neurotransmitters, hormones and other factors. Recovery activity can be reflected both in the clinical assessment of the patient (based on the NIHSS or MRS scale for example) as well as on the biochemical and molecular level. This study aims to search biomarkers that prognose brain repair ability and consequently estimate an outcome of stroke patients. The prognostic value of proteins VEGF, IGF-1 and MMP-9 and expression of genes VEGF, IGF-1, MMP-9 is evaluated in association with clinical scales including cognitive assessment scales and depression scales. Furthermore, the collected data will be analyzed in relation to demographics and vascular risk factors. Blood sample collection as well as scales recording are taken at baseline and 3 weeks later after rehabilitation. The study group patients will undergo standard post-stroke rehabilitation programme provided by physiotherapist, every day for a period of 3 weeks with weekend gaps.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subacute ischemic stroke patients received standard therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subacute ischeamic stroke,\n* age over 18,\n* informed consent obtained\n\nExclusion Criteria:\n\n* intracerebral haemorrhage,\n* chronic or significant acute inflammatory factors,\n* neurological illness other than ischeamic stroke,\n* severe cardio-vascular disease like myocardial infarction less than 30 days, unstable angina pectoris,\n* decompensated metabolic or endocrine diseases'}, 'identificationModule': {'nctId': 'NCT05750303', 'briefTitle': 'Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Lodz'}, 'officialTitle': 'Circulating Serum VEGF, IGF-1 and MMP-9 and Expression of Their Genes as Potential Prognostic Markers of Recovery in Post-stroke Rehabilitation - Prospective Observational Study', 'orgStudyIdInfo': {'id': 'RNN/105/21/KE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Subacute ischemic stroke', 'description': 'blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples'}, {'label': 'No ischemic stroke and no other neurological disease control group', 'description': 'blood sample collection to determine VEGF, IGF-1 and MMP-9 level in plasma and expression of genes VEGF, IGF-1, MMP-9 in whole blood samples'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93-113', 'city': 'Lodz', 'country': 'Poland', 'facility': 'Medical University of Lodz', 'geoPoint': {'lat': 51.77058, 'lon': 19.47395}}], 'overallOfficials': [{'name': 'Elzbieta Miller, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Lodz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Lodz', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Lodz', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}