Retinal vessel imaging with OCTA in people with cardiovascular disease and healthy volunteers.
Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group
We will try retinal imaging (OCTA and SLDF) to measure blood vessels in the eyes of people with cardiovascular disease and healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Erlangen-Nürnberg Medical School Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT07359664 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with cardiovascular disease (one or more of arterial hypertension, type 2 diabetes, chronic kidney disease, or heart failure) or healthy adults who are non-smokers with BMI 18–29.9 kg/m2 and no active retinal disease.
Not a fit: Patients with active ophthalmological conditions that impair retinal imaging (for example glaucoma, cataract, or retinal edema) or those unable to attend the imaging visits are unlikely to receive benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a non-invasive biomarker to detect microvascular damage related to cardiovascular disease and help monitor vascular health.
How similar studies have performed: Similar retinal imaging approaches, including OCTA and laser Doppler methods, have been widely used and shown promise for detecting microvascular changes in cardiovascular and metabolic disease, though some measures and reproducibility remain under refinement.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Erlangen, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.