Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
研究概览
简要总结
To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •Personal medical history of retinal neovascularization.
- •Unable or unwilling to give consent
研究组 & 干预措施
Diastolic heart failure
干预措施: SphygmoCor (Diagnostic Test)
Diastolic heart failure
干预措施: Sphygmomanometer (Diagnostic Test)
Diastolic heart failure
干预措施: Blood sample (Diagnostic Test)
Diastolic heart failure
干预措施: Skin biopsy (Diagnostic Test)
Diastolic heart failure
干预措施: Neuropsychological examination (Diagnostic Test)
Healthy patients
干预措施: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Healthy patients
干预措施: Fundus pictures (Diagnostic Test)
Healthy patients
干预措施: DVA 3.0 (Diagnostic Test)
Healthy patients
干预措施: Hyperspectral retinal images (Diagnostic Test)
Healthy patients
干预措施: SphygmoCor (Diagnostic Test)
Healthy patients
干预措施: Sphygmomanometer (Diagnostic Test)
Healthy patients
干预措施: Blood sample (Diagnostic Test)
Healthy patients
干预措施: Skin biopsy (Diagnostic Test)
Healthy patients
干预措施: Neuropsychological examination (Diagnostic Test)
Chronic kidney disease
干预措施: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Chronic kidney disease
干预措施: Fundus pictures (Diagnostic Test)
Chronic kidney disease
干预措施: DVA 3.0 (Diagnostic Test)
Chronic kidney disease
干预措施: Hyperspectral retinal images (Diagnostic Test)
Chronic kidney disease
干预措施: SphygmoCor (Diagnostic Test)
Chronic kidney disease
干预措施: Sphygmomanometer (Diagnostic Test)
Chronic kidney disease
干预措施: Blood sample (Diagnostic Test)
Chronic kidney disease
干预措施: Skin biopsy (Diagnostic Test)
Chronic kidney disease
干预措施: Neuropsychological examination (Diagnostic Test)
Diastolic heart failure
干预措施: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Diastolic heart failure
干预措施: Fundus pictures (Diagnostic Test)
Diastolic heart failure
干预措施: DVA 3.0 (Diagnostic Test)
Diastolic heart failure
干预措施: Hyperspectral retinal images (Diagnostic Test)
Neuronal small vessel disease
干预措施: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Neuronal small vessel disease
干预措施: Fundus pictures (Diagnostic Test)
Neuronal small vessel disease
干预措施: DVA 3.0 (Diagnostic Test)
Neuronal small vessel disease
干预措施: Hyperspectral retinal images (Diagnostic Test)
Neuronal small vessel disease
干预措施: SphygmoCor (Diagnostic Test)
Neuronal small vessel disease
干预措施: Sphygmomanometer (Diagnostic Test)
Neuronal small vessel disease
干预措施: Blood sample (Diagnostic Test)
Neuronal small vessel disease
干预措施: Skin biopsy (Diagnostic Test)
Neuronal small vessel disease
干预措施: Neuropsychological examination (Diagnostic Test)
Glaucoma
干预措施: Optical coherence tomography(-angiography) OCT(A) (Diagnostic Test)
Glaucoma
干预措施: Fundus pictures (Diagnostic Test)
Glaucoma
干预措施: DVA 3.0 (Diagnostic Test)
Glaucoma
干预措施: Hyperspectral retinal images (Diagnostic Test)
Glaucoma
干预措施: SphygmoCor (Diagnostic Test)
Glaucoma
干预措施: Sphygmomanometer (Diagnostic Test)
Glaucoma
干预措施: Blood sample (Diagnostic Test)
Glaucoma
干预措施: Skin biopsy (Diagnostic Test)
Glaucoma
干预措施: Neuropsychological examination (Diagnostic Test)
结局指标
主要结局
Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
时间窗: 3 years
次要结局
- 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)