Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-02-21 @ 10:34 AM
Study NCT ID:
NCT02265003
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2014-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Red Blood Cells as a Reflection of Endothelial Function in Old Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2014-10-09', 'studyFirstSubmitQcDate': '2014-10-09', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of endothelial function', 'timeFrame': 'baseline', 'description': 'measured as flow-mediated vasodilation'}], 'secondaryOutcomes': [{'measure': 'Determination of nitric oxide(NO)-pool in red blood cells and blood plasma', 'timeFrame': 'baseline'}, {'measure': 'Determination of erythrocytes parameter', 'timeFrame': 'baseline', 'description': 'It will be determinated: oxidative status, signalling of nitric oxide, function, creation, amount and aging of red blood cells, cell-to-cell-interaction, microRNA and inflammation'}, {'measure': 'Cardiovascular Parameter', 'timeFrame': 'baseline', 'description': 'It will be determinated: hemodynamic, microcirculation and physicomechanic'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['red blood cells', 'endothelial function', 'nitric oxide pool in red blood cells', 'nitric oxide poll in blood plasma', 'nitric oxide synthase III - expression', 'oxidative status', 'nitric oxide signalling'], 'conditions': ['Red Blood Cells', 'Endothelial Function', 'Nitric Oxide Pool in Red Blood Cells and Blood Plasma']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to find out, how far red blood cells reflect age-depended changes in endothelial function.', 'detailedDescription': 'It will be investigated with determination of endothelial function (measured as flow-mediated vasodilation) and of circulated nitric oxid-pool in red blood cells and in blood plasma, how far red blood cells reflect age-depended changes in endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '4 groups:\n\n* healthy young aged 18-35 years (30 subjects)\n* healthy middel aged 35-45 years (30 subjects)\n* healthy old aged \\> 70 years (30 subjects)\n* patients (50 subjects)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Groups 1-3:\n\nInclusion Criteria:\n\n* healthy subjects\n* informed consent\n\nExclusion Criteria:\n\n* hypertension (blood pressure ≥140/90 mmHg),\n* hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),\n* diabetes mellitus (fasting plasma glucose ≥128 mg/dl)\n* acute inflammation (CRP \\>0.5 mg/dl)\n* malignant diseases\n* heart failure (NYHA III-IV)\n* arrhythmia of high degree\n* acute or terminated kidney disease\n* cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)\n* anemia\n* pregnancy\n\nGroup 4 :\n\nInclusion Criteria:\n\n* angiographical signs of apparent atherosclerosis (cardiac artery disease or peripheral vascular disease or degenerative valvular heart disease)\n* informed consent\n\nExclusion Criteria:\n\n* Hypertension (blood pressure ≥140/90 mmHg),\n* Hypercholesterolemia (LDL ≥250 mg/dl, HDL ≤45 mg/dl),\n* Diabetes mellitus (fasting plasma glucose ≥128 mg/dl)\n* acute inflammation (CRP \\>0.5 mg/dl)\n* malignant diseases\n* heart failure (NYHA III-IV)\n* arrhythmia of high degree\n* acute or terminated kidney disease\n* cardiovascular diseases ( cardiac artery disease, peripheral vascular disease and cerebrovascular diseases)\n* anemia\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02265003', 'briefTitle': 'Red Blood Cells as a Reflection of Endothelial Function in Old Age', 'organization': {'class': 'OTHER', 'fullName': 'Heinrich-Heine University, Duesseldorf'}, 'officialTitle': 'Red Blood Cells as a Reflection of Endothelial Function in Old Age', 'orgStudyIdInfo': {'id': 'Anaemie'}, 'secondaryIdInfos': [{'id': '14-016', 'type': 'OTHER', 'domain': 'CTSU'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy young age', 'description': 'Healthy subjects in age of 18-35 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease'}, {'label': 'Healthy middle age', 'description': 'Healthy subjects in age of 35-45 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease'}, {'label': 'Healthy old', 'description': 'Healthy subjects in age of \\>70 years, without cardiac dysrhythmia, hypertension, diabetes mellitus, acute inflammations and terminal kidney disease'}, {'label': 'Patients', 'description': 'Patients with atherosclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'facility': 'University Hospital Duesseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Malte Kelm, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cardiology, Pneumology and Angiology, University Hospital Duesseldorf'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heinrich-Heine University, Duesseldorf', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator Prof. Dr. Malte Kelm', 'investigatorFullName': 'Klinik für Kardiologie, Pneumologie und Angiologie', 'investigatorAffiliation': 'Heinrich-Heine University, Duesseldorf'}}}}