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Recruiting NCT07359664

OCTA in Cardiovascular Disease and Healthy Controls

No phase Interventional Patients With Cardiovascular Disease Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retinal vascular assessment using OCTA and SLDF.
Who it may be relevant to
Registry conditions: Patients With Cardiovascular Disease, Healthy Participants. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Optical Coherence Tomography Angiography (OCTA) for the Assessment of Retinal Capillary Density in Patients With Cardiovascular Disease and a Healthy Control Group

Overview

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.

Detailed 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.

Interventions

  • Diagnostic test Retinal vascular assessment using OCTA and SLDF
    Assessment of retinal capillary density using OCTA and SLDF

Primary outcome measures

  • Assessment of reliability of OCTA based assessment of retinal capillary density in patients with CV disease [Time frame: 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)]
Secondary outcome measures (1)
  • comparison of OCTA based retinal capillary density between CV diseased patients and healthy controls [Time frame: one study visit in each group, baseline values at day 1 are compared]

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 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Germany · 1 center
  • University of Erlangen Nuremberg — Erlangen

Identifiers

NCT: NCT07359664 · OCTA_CVD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗