OCTA in Cardiovascular Disease and Healthy Controls (NCT07359664) | Clinical Trial Compass
RecruitingNot Applicable
OCTA in Cardiovascular Disease and Healthy Controls
Germany64 participantsStarted 2025-12-01
Plain-language summary
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 participate
Age range18 Years – 75 Years
SexALL
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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 ant…
What they're measuring
1
Assessment of reliability of OCTA based assessment of retinal capillary density in patients with CV disease
Timeframe: test-retest-reliability between 3 study visits (between each visit needs to be a time gap of at least 24 hours, all visits will be performed within two weeks)
Trial details
NCT IDNCT07359664
SponsorUniversity of Erlangen-NĂĽrnberg Medical School