Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 1,000
- Locations
- 1
- Primary Endpoint
- Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Personal medical history of retinal neovascularization.
- •Unable or unwilling to give consent
Arms & Interventions
Diastolic heart failure
Intervention: SphygmoCor (Diagnostic Test)
Diastolic heart failure
Intervention: Sphygmomanometer (Diagnostic Test)
Diastolic heart failure
Intervention: Blood sample (Diagnostic Test)
Diastolic heart failure
Intervention: Skin biopsy (Diagnostic Test)
Diastolic heart failure
Intervention: Neuropsychological examination (Diagnostic Test)
Healthy patients
Intervention: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Healthy patients
Intervention: Fundus pictures (Diagnostic Test)
Healthy patients
Intervention: DVA 3.0 (Diagnostic Test)
Healthy patients
Intervention: Hyperspectral retinal images (Diagnostic Test)
Healthy patients
Intervention: SphygmoCor (Diagnostic Test)
Healthy patients
Intervention: Sphygmomanometer (Diagnostic Test)
Healthy patients
Intervention: Blood sample (Diagnostic Test)
Healthy patients
Intervention: Skin biopsy (Diagnostic Test)
Healthy patients
Intervention: Neuropsychological examination (Diagnostic Test)
Chronic kidney disease
Intervention: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Chronic kidney disease
Intervention: Fundus pictures (Diagnostic Test)
Chronic kidney disease
Intervention: DVA 3.0 (Diagnostic Test)
Chronic kidney disease
Intervention: Hyperspectral retinal images (Diagnostic Test)
Chronic kidney disease
Intervention: SphygmoCor (Diagnostic Test)
Chronic kidney disease
Intervention: Sphygmomanometer (Diagnostic Test)
Chronic kidney disease
Intervention: Blood sample (Diagnostic Test)
Chronic kidney disease
Intervention: Skin biopsy (Diagnostic Test)
Chronic kidney disease
Intervention: Neuropsychological examination (Diagnostic Test)
Diastolic heart failure
Intervention: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Diastolic heart failure
Intervention: Fundus pictures (Diagnostic Test)
Diastolic heart failure
Intervention: DVA 3.0 (Diagnostic Test)
Diastolic heart failure
Intervention: Hyperspectral retinal images (Diagnostic Test)
Neuronal small vessel disease
Intervention: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Neuronal small vessel disease
Intervention: Fundus pictures (Diagnostic Test)
Neuronal small vessel disease
Intervention: DVA 3.0 (Diagnostic Test)
Neuronal small vessel disease
Intervention: Hyperspectral retinal images (Diagnostic Test)
Neuronal small vessel disease
Intervention: SphygmoCor (Diagnostic Test)
Neuronal small vessel disease
Intervention: Sphygmomanometer (Diagnostic Test)
Neuronal small vessel disease
Intervention: Blood sample (Diagnostic Test)
Neuronal small vessel disease
Intervention: Skin biopsy (Diagnostic Test)
Neuronal small vessel disease
Intervention: Neuropsychological examination (Diagnostic Test)
Glaucoma
Intervention: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Glaucoma
Intervention: Fundus pictures (Diagnostic Test)
Glaucoma
Intervention: DVA 3.0 (Diagnostic Test)
Glaucoma
Intervention: Hyperspectral retinal images (Diagnostic Test)
Glaucoma
Intervention: SphygmoCor (Diagnostic Test)
Glaucoma
Intervention: Sphygmomanometer (Diagnostic Test)
Glaucoma
Intervention: Blood sample (Diagnostic Test)
Glaucoma
Intervention: Skin biopsy (Diagnostic Test)
Glaucoma
Intervention: Neuropsychological examination (Diagnostic Test)
Outcomes
Primary Outcomes
Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
Time Frame: 3 years
Secondary Outcomes
- Physiological behaviour of retinal vasculature under cardiovascular stress.(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 functioning(3 years)
- Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.(3 years)
- Histopathological correlates in dermal microvasculature(3 years)