Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-28 @ 8:50 PM
Study NCT ID:
NCT06485128
Status:
UNKNOWN
Last Update Posted:
2024-07-03
First Post:
2023-10-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-26', 'studyFirstSubmitDate': '2023-10-05', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.', 'timeFrame': '3 years'}, {'measure': 'The association between these parameters and (1) the presence of risk factors for cardiovascular disease (including biomarkers) and (2) risk factors for disease progression and (3) neuropsychological functioning', 'timeFrame': '3 years'}, {'measure': 'Physiological behaviour of retinal vasculature under cardiovascular stress.', 'timeFrame': '3 years'}, {'measure': 'Histopathological correlates in dermal microvasculature', 'timeFrame': '3 years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Diseases', 'Diastolic Heart Failure', 'Small Vessel Disease', 'Glaucoma']}, 'descriptionModule': {'briefSummary': 'To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.', 'detailedDescription': 'In this interventional cohort study, the investigators aim to evaluate retinal vascular function as assessed by optical coherence tomography angiography, fundus photography and dynamic vessel analysis in patients who share microvascular involvement of their pathology (e.g. chronic kidney disease, cardiac decompensation, neuronal small vessel disease and glaucoma) and age-matched healthy controls. Plasm and skin samples for comparative proteomics and transcriptomics are also taken.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with a confirmed or suspect diagnosis of glaucoma based on intra-ocular eye pressure, visual field defect and structural optic nerve changes, regardless their age.\n* Adult patients with chronic kidney disease regardless their age.\n* Adult patients with heart failure with preserved ejection fraction (HFpEF), regardless their age: symptomatic heart failure with Left Ventricle Ejection Fraction \\> 50% AND BNP \\> 35 pg/ml (or NT-proBNP\\>125 pg/ml) OR signs of diastolic dysfunction according to the European Society of Cardiology guidelines 2016\n* Adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age.\n* People without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age\n* Capable and willing to participate (informed consent)\n\nExclusion Criteria:\n\n* Diabetes\n* Personal medical history of retinal neovascularization.\n* Unable or unwilling to give consent'}, 'identificationModule': {'nctId': 'NCT06485128', 'briefTitle': 'Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease', 'orgStudyIdInfo': {'id': 'S63649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Chronic kidney disease', 'interventionNames': ['Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)', 'Diagnostic Test: Fundus pictures', 'Diagnostic Test: DVA 3.0', 'Diagnostic Test: Hyperspectral retinal images', 'Diagnostic Test: SphygmoCor', 'Diagnostic Test: Sphygmomanometer', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Skin biopsy', 'Diagnostic Test: Neuropsychological examination']}, {'type': 'OTHER', 'label': 'Diastolic heart failure', 'interventionNames': ['Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)', 'Diagnostic Test: Fundus pictures', 'Diagnostic Test: DVA 3.0', 'Diagnostic Test: Hyperspectral retinal images', 'Diagnostic Test: SphygmoCor', 'Diagnostic Test: Sphygmomanometer', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Skin biopsy', 'Diagnostic Test: Neuropsychological examination']}, {'type': 'OTHER', 'label': 'Neuronal small vessel disease', 'interventionNames': ['Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)', 'Diagnostic Test: Fundus pictures', 'Diagnostic Test: DVA 3.0', 'Diagnostic Test: Hyperspectral retinal images', 'Diagnostic Test: SphygmoCor', 'Diagnostic Test: Sphygmomanometer', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Skin biopsy', 'Diagnostic Test: Neuropsychological examination']}, {'type': 'OTHER', 'label': 'Glaucoma', 'interventionNames': ['Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)', 'Diagnostic Test: Fundus pictures', 'Diagnostic Test: DVA 3.0', 'Diagnostic Test: Hyperspectral retinal images', 'Diagnostic Test: SphygmoCor', 'Diagnostic Test: Sphygmomanometer', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Skin biopsy', 'Diagnostic Test: Neuropsychological examination']}, {'type': 'OTHER', 'label': 'Healthy patients', 'interventionNames': ['Diagnostic Test: Optical coherence tomography(-angiography) OCT(A)', 'Diagnostic Test: Fundus pictures', 'Diagnostic Test: DVA 3.0', 'Diagnostic Test: Hyperspectral retinal images', 'Diagnostic Test: SphygmoCor', 'Diagnostic Test: Sphygmomanometer', 'Diagnostic Test: Blood sample', 'Diagnostic Test: Skin biopsy', 'Diagnostic Test: Neuropsychological examination']}], 'interventions': [{'name': 'Optical coherence tomography(-angiography) OCT(A)', 'type': 'DIAGNOSTIC_TEST', 'description': 'OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Fundus pictures', 'type': 'DIAGNOSTIC_TEST', 'description': 'Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'DVA 3.0', 'type': 'DIAGNOSTIC_TEST', 'description': 'IMEDOS GmbH', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Hyperspectral retinal images', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ximea SNm4x4 hyperspectral snapshot camera', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'SphygmoCor', 'type': 'DIAGNOSTIC_TEST', 'description': 'Sphygmocor Excell', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Sphygmomanometer', 'type': 'DIAGNOSTIC_TEST', 'description': 'For the measurement of the blood pressure.', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Skin biopsy', 'type': 'DIAGNOSTIC_TEST', 'description': 'Spatial proteomics and transcriptomics for endothelial function.', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}, {'name': 'Neuropsychological examination', 'type': 'DIAGNOSTIC_TEST', 'description': 'Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS', 'armGroupLabels': ['Chronic kidney disease', 'Diastolic heart failure', 'Glaucoma', 'Healthy patients', 'Neuronal small vessel disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams-Brabant', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sarah Spileers, SC', 'role': 'CONTACT', 'email': 'oogziekten.glaucoomstudies@uzleuven.be', 'phone': '+32 16 34 03 91'}, {'name': 'Amaryllis Van Craenenbroeck, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jan Van Eijgen, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Véronique Cornelissen, MD, PHD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Elisabeth Jones, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mathieu Vandenbulcke, MD, PHD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Universitaire Ziekenhuizen UZ/KU Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Jan Van Eijgen, MD', 'role': 'CONTACT', 'email': 'jan.1.vaneijgen@uzleuven.be', 'phone': '+32 16 34 56 28'}, {'name': 'Sarah Spileers, SC', 'role': 'CONTACT', 'email': 'oogziekten.glaucoomstudies@uzleuven.be', 'phone': '+32 16 34 03 91'}], 'overallOfficials': [{'name': 'Ingeborg Stalmans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}