Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
NCT ID: NCT06485128
Last Updated: 2024-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
1000 participants
INTERVENTIONAL
2021-07-06
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Chronic kidney disease
Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Diastolic heart failure
Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Neuronal small vessel disease
Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Glaucoma
Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Healthy patients
Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Interventions
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Optical coherence tomography(-angiography) OCT(A)
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.
Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
DVA 3.0
IMEDOS GmbH
Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
SphygmoCor
Sphygmocor Excell
Sphygmomanometer
For the measurement of the blood pressure.
Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Eligibility Criteria
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Inclusion Criteria
* Adult patients with chronic kidney disease regardless their age.
* 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
* Adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age.
* People without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age
* Capable and willing to participate (informed consent)
Exclusion Criteria
* Personal medical history of retinal neovascularization.
* Unable or unwilling to give consent
18 Years
ALL
Yes
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Principal Investigators
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Ingeborg Stalmans, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Locations
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Universitaire Ziekenhuizen UZ/KU Leuven
Leuven, Vlaams-Brabant, Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S63649
Identifier Type: -
Identifier Source: org_study_id
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