Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 64
研究概览
简要总结
This prospective clinical study will involve the non-invasive assessment of retinal vessels using OCTA (Cirrus OCT 6000 AngioPlex) and scanning laser Doppler flowmetry (SLDF) in patients with cardiovascular disease and healthy individuals. The study will be conducted at the Clinical Research Centre (CRC), Department of Nephrology and Hypertension at the University of Erlangen-Nuremberg.
详细描述
Each patient (32 patients) and healthy individual (32 healthy individuals) undergoes one study visit. After providing informed consent, each patient and healthy individual receives an assessment of their retinal vessels using OCTA and SLDF. In the sub-study of 10 patients with cardiovascular disease, the reliability of the OCTA measurements will be determined. Each patient will receive three study visits (with an OCTA and SLDF assessment on each occasion) on three different days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients with cardiovascular disease:
- •cardiovascular disease defined as one or more of the following: arterial hypertension, type 2 diabetes mellitus, chronic kidney disease, heart failure
- •Inclusion Criteria for healthy individuals:
- •BMI 18-29.9 kg/m2
- •Non-smoker
- •Good general health, as determined by study personnel based on assessments of previous visits, including anamnesis, vital signs, physical examination and clinical laboratory parameters.
排除标准
- •for patients with cardiovascular disease:
- •Active ophthalmological (retinal) disease resulting in impaired visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
- •Exclusion criteria for healthy individuals:
- •Active ophthalmological (retinal) disease with reduced visual assessment of retinal vessels (e.g. glaucoma, cataracts, retinal oedema).
- •clinically relevant deviation in physical examination, vital signs, or laboratory parameters (based on the physician's clinical judgement).
- •a clinically relevant history of cardiovascular disease or any other previously known cardiovascular disease
- •History of clinically relevant neurological, gastrointestinal, renal, hepatic, psychological, pulmonary, metabolic, endocrine or other diseases
- •office blood pressure above or equal to 140/90 mmHg
- •Office heart rate outside of the following range: 50-99 bpm
- •regular intake of any medication for the treatment of cardiovascular diseases (e.g. antihypertensive or antidiabetic medication) within one month before study inclusion
- •alcohol or drug abuse