Clinical trial NCT06442176: Choroid In Coronary Artery Disease
Official title: Choroid Thickness May Shed Light On Early Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choroid Diseases
Keywords: Coronary Artery Disease
Choroid
Gensini Score
Optical Coherence Tomography
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-06-04
Enrollment: 128
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants had coronary angiography performed by the Department of Cardiology on an elective scheduled basis following ischaemic changes detected on treadmill stress test or at least 5% ischaemic burden determined at conventional single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI).

Brief summary: Purpose: To investigate any relationship between choroid thickness (CTh) and coronary artery disease (CAD), particularly in its earlier stages before clinically evident.

Design: Retrospective, cross-sectional observational study

Methods:

Setting: The study was performed in two institutions; patients were recruited in Balikesir City Hospital. The ophthalmological examinations and coronary angiograms were performed in Balikesir City Hospital. The analysis of the coronary angiograms including Gensini scoring were conducted in Bursa Education and Research Hospital.

Study Population: The study group comprised 68 patients with documented CAD and 60 healthy control subjects. Patients with high myopia, cataracts, retinal vascular disease, retinal surgery, retinal dystrophy, laser photocoagulation, intravitreal anti-VEGF treatment, glaucoma, uveitis, retinal disorders, any systemic diseases were excluded from the study groups.

Observation Procedure: Refractive examination, corrected visual acuity, intraocular pressure measurements, anterior and posterior segment examinations. Following measurements of macular thickness and retinal nerve fiber layer, choroidal thickness of both eyes was assessed by enhanced depth imaging optical coherence tomography.


Eligibility criteria: Inclusion Criteria:

* Normal coronaries at coronary angiography for healthy control group
* Without any coronary artery disease equivalent diseases such as peripheral artery disease, cerebrovascular disease and stroke for healthy control group
* Ability to give informed consent for the study
* Coronary artery disease with stenosis detected in coronary angiogram for coronary artery disease group

Exclusion Criteria:

* High myopia (\> 6D)
* Cataracts
* Retinal vascular disease
* Retinal surgery
* Retinal dystrophy
* Laser photocoagulation
* Intravitreal anti-VEGF treatment
* Glaucoma
* Uveitis
* Retinal disorders (comprising diabetic macular edema, diabetic/hypertensive retinopathy, vein occlusions, retinal dystrophy, epiretinal membrane, vitreomacular traction, age-related macular degeneration)
* Any systemic diseases
* Obesity (body-mass index ≥30 kg/m²)

Primary outcomes:
measure: Choroidal thickness in Healthy Subjects
timeFrame: 1 day
measure: Choroidal thickness in patients with coronary artery disease
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Balikesir City Hospital
Study officials:
affiliation: Balikesir City Hospital
name: Hakan Tenekecioglu, MD
role: STUDY_DIRECTOR
affiliation: Balikesir City Hospital
name: Iskender Kadife, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saglik Bilimleri Universitesi
name: Erhan Tenekecioglu
role: PRINCIPAL_INVESTIGATOR
References: