Choroid DiseasesNCT06442176
Choroid In Coronary Artery Disease
An observational study of Choroid Diseases, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Choroid Diseases
- What is being tested?
- OCT
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2021to 21 Apr 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- High myopia (> 6D)
- Cataracts
- Retinal vascular disease
- Retinal surgery
- Retinal dystrophy
- Laser photocoagulation
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read more
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
- Being tested
- OCT
- Keywords
- Coronary Artery Disease, Choroid, Gensini Score, Optical Coherence Tomography
- Medical subject headings
- Choroid Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDiagnostic test
Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)
| Study group | Role | What they receive |
|---|---|---|
| Control Healthy group | Not described Receives: Diagnostic Test: OCT | |
| Coronary Artery Disease Group | Not described Receives: Diagnostic Test: OCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choroidal thickness in Healthy Subjects
micron
Measured: 1 day
Choroidal thickness in patients with coronary artery disease
micron
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Mar 2021
- Primary completion1 Mar 2023
- Study completion21 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroid DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 128 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ERHAN TENEKECIOGLU, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Hakan Tenekecioglu, MD, Study director, Balikesir City HospitalIskender Kadife, MD, Principal investigator, Balikesir City HospitalErhan Tenekecioglu, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442176
- Sponsor's protocol ID
- BSH-131/21
- Status last verified
- Jun 2024
- First submitted
- 27 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choroid Thickness May Shed Light On Early Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06442176
- Acronym / sponsor ID
- BSH-131/21
- Conditions
- Choroid Diseases
- Keywords
- Coronary Artery Disease, Choroid, Gensini Score, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 21 Apr 2024 (actual)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Healthy group | – | Diagnostic Test: OCT |
| Coronary Artery Disease Group | – | Diagnostic Test: OCT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- High myopia (> 6D)
- Cataracts
- Retinal vascular disease
- Retinal surgery
- Retinal dystrophy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTEnhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA) | Diagnostic test | Control Healthy group, Coronary Artery Disease Group |
Primary outcome
Choroidal thickness in Healthy Subjects
Time frame: 1 day
micron
Choroidal thickness in patients with coronary artery disease
Time frame: 1 day
micron
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hakan Tenekecioglu, MD study director
Balikesir City Hospital
Iskender Kadife, MD principal investigator
Balikesir City Hospital
Erhan Tenekecioglu principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Choroid Diseases, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choroidal thickness in Healthy Subjects (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.