OCTA in Cardiovascular Disease and Healthy Controls

University of Erlangen-Nürnberg Medical School

Status

Enrolling

Conditions

Healthy Participants

Patients With Cardiovascular Disease

Treatments

Diagnostic Test: Retinal vascular assessment using OCTA and SLDF

Study type

Interventional

Funder types

Other

Identifiers

NCT07359664

OCTA_CVD

Details and patient eligibility

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.

Full description

Each patient (32 patients) and healthy individual (32 healthy individuals) undergoes one study visit. After providing informed consent, each patient and healthy individual receives an assessment of their retinal vessels using OCTA and SLDF. In the sub-study of 10 patients with cardiovascular disease, the reliability of the OCTA measurements will be determined. Each patient will receive three study visits (with an OCTA and SLDF assessment on each occasion) on three different days.

Enrollment

64 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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