Choroid In Coronary Artery Disease

NCT06442176 | Completed

• 1 other identifier: BSH-131/21
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Choroid Diseases

Keywords

Coronary Artery Disease; Choroid; Gensini Score; Optical Coherence Tomography

Outcome Measures

Primary Outcomes (2)

• Choroidal thickness in Healthy Subjects

  micron

  1 day

• Choroidal thickness in patients with coronary artery disease

  micron

  1 day

Study Arms (2)

Control Healthy group

Diagnostic Test: OCT

Coronary Artery Disease Group

Diagnostic Test: OCT

Interventions

OCT DIAGNOSTIC_TEST

Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)

Control Healthy group; Coronary Artery Disease Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Balikesir City Hospital

Balıkesir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Choroid Diseases; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Hakan Tenekecioglu, MD

  Balikesir City Hospital

  STUDY DIRECTOR

• Iskender Kadife, MD

  Balikesir City Hospital

  PRINCIPAL INVESTIGATOR

• Erhan Tenekecioglu

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 4, 2024
• Study Start: March 1, 2021
• Primary Completion: March 1, 2023
• Study Completion: April 21, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)