OCTA in Cardiovascular Disease and Healthy Controls
Recruiting · NCT07359664 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Erlangen-Nürnberg Medical School
View the official record on ClinicalTrials.gov →Interventions studied
Retinal vascular assessment using OCTA and SLDF
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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
Where it is running
1 location listed.
- University of Erlangen Nuremberg - Erlangen, Bavaria, Germany