Choroid In Coronary Artery Disease

NCT ID: NCT06442176

Last Updated: 2024-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-04-21

Brief Summary

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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.

Detailed Description

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Conditions

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Choroid Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Control Healthy group

OCT

Intervention Type DIAGNOSTIC_TEST

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

Coronary Artery Disease Group

OCT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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OCT

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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ERHAN TENEKECIOGLU

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan Tenekecioglu, MD

Role: STUDY_DIRECTOR

Balikesir City Hospital

Iskender Kadife, MD

Role: PRINCIPAL_INVESTIGATOR

Balikesir City Hospital

Erhan Tenekecioglu

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Balikesir City Hospital

Balıkesir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BSH-131/21

Identifier Type: -

Identifier Source: org_study_id

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