OCTA in Cardiovascular Disease and Healthy Controls
Recruiting
N/AInterventional Study
Patients With Cardiovascular DiseaseHealthy Participants
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Diagnostic
Participants needed
64 (estimated)
Sponsor
University of Erlangen-Nürnberg Medical School · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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…
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
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