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Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06485128
Enrollment
1000
Registered
2024-07-03
Start date
2021-07-06
Completion date
2024-12-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Diseases, Diastolic Heart Failure, Small Vessel Disease, Glaucoma

Brief summary

To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTOptical 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.

DIAGNOSTIC_TESTFundus pictures

Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)

DIAGNOSTIC_TESTDVA 3.0

IMEDOS GmbH

DIAGNOSTIC_TESTHyperspectral retinal images

Ximea SNm4x4 hyperspectral snapshot camera

DIAGNOSTIC_TESTSphygmoCor

Sphygmocor Excell

DIAGNOSTIC_TESTSphygmomanometer

For the measurement of the blood pressure.

DIAGNOSTIC_TESTBlood sample

For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).

DIAGNOSTIC_TESTSkin biopsy

Spatial proteomics and transcriptomics for endothelial function.

Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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. * 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

* Diabetes * Personal medical history of retinal neovascularization. * Unable or unwilling to give consent

Design outcomes

Primary

MeasureTime frame
Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.3 years

Secondary

MeasureTime frame
Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.3 years
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 functioning3 years
Physiological behaviour of retinal vasculature under cardiovascular stress.3 years
Histopathological correlates in dermal microvasculature3 years

Countries

Belgium

Contacts

Primary ContactJan Van Eijgen, MD
jan.1.vaneijgen@uzleuven.be+32 16 34 56 28
Backup ContactSarah Spileers, SC
oogziekten.glaucoomstudies@uzleuven.be+32 16 34 03 91

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026