Choroid In Coronary Artery Disease

June 2, 2024 updated by: ERHAN TENEKECIOGLU, Bursa Yüksek İhtisas Education and Research Hospital

Choroid Thickness May Shed Light On Early Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balıkesir, Turkey
        • Balikesir City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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).

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Healthy group
Diagnostic test: OCT
Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)
Coronary Artery Disease Group
Diagnostic test: OCT
Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Choroidal thickness in Healthy Subjects
Time Frame: 1 day
micron
1 day
Choroidal thickness in patients with coronary artery disease
Time Frame: 1 day
micron
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Study Director: Hakan Tenekecioglu, MD, Balikesir City Hospital
  • Principal Investigator: Iskender Kadife, MD, Balikesir City Hospital
  • Principal Investigator: Erhan Tenekecioglu, Saglik Bilimleri Universitesi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

March 1, 2023

Study Completion (Actual)

April 21, 2024

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 2, 2024

First Posted (Estimated)

June 4, 2024

Study Record Updates

Last Update Posted (Estimated)

June 4, 2024

Last Update Submitted That Met QC Criteria

June 2, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BSH-131/21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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