Retinal vessel imaging with OCTA in people with cardiovascular disease and healthy volunteers.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective interventional project uses non-invasive retinal imaging — Cirrus OCT 6000 AngioPlex OCTA and scanning laser Doppler flowmetry (SLDF) — to quantify retinal microvasculature in 32 patients with cardiovascular disease and 32 healthy controls. Each participant has one imaging visit, and a sub-study of 10 patients with cardiovascular disease will have three separate visits to test measurement reliability. Recruitment and imaging take place at the Clinical Research Centre, Department of Nephrology and Hypertension, University of Erlangen-Nürnberg. Collected data will compare retinal vascular parameters between groups and assess reproducibility of OCTA measures.

Why it matters

Who can join: the full rules

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's running

• University of Erlangen Nuremberg
  Erlangen, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Agnes Bosch, MD — Clinical Research Center, Department of Nephrology and Hypertension, Universityhospital Erlangen
• Study coordinator: Agnes Bosch, MD
• Email: agnes.bosch@uk-erlangen.de
• Phone: +49 9131 8536245

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.