Can we Predict COronary Resistance By EYE Examination ? (COREYE) (COREYE)
Primary Purpose
Coronary Artery Disease
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
OCTA (angiography by tomography in optical coherence)
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease
Eligibility Criteria
Inclusion Criteria:
- Male and female patient's ≥18 years of age with coronary arterial indication as usual and with proximal and / or mean IVA stenosis ≥ 50%.
- Signed informed consent
- Affiliation to the social security system
Exclusion Criteria:
- Unstable Coronary Artery Disease
- Atrial fibrillation
- History of myocardial infarction <6 months in the territory of the proximal and / or mean IVA.
- Asthma
- Aortocoronary bypass surgery.
- Collateral development at the level of the proximal and / or mean IVA.
- Allergy to iodine, severe renal insufficiency.
- Ametropia> = 6 diopters.
- History of retinal ocular pathologies other than uncomplicated diabetic retinopathy and hypertensive retinopathy.
- History of ophthalmic treatments such as macular or panretinal laser photocoagulation, intravitreal injection of anti-VEGF or cortisone.
- Chronic glaucoma
- Patients under guardianship or curators.
- Pregnant or lactating women.
- Patient's not affiliated to the French social security.
- Persons placed under the protection of justice,
- Subject participating in another research including an exclusion period still in progress at pre-inclusion
Sites / Locations
- Hospices Civils de Lyon - Hopital de la Croix RousseRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with coronary arterial indication
Arm Description
A fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed for patients with intermediate stenosis of the left anterior descending artery (LDA).
Outcomes
Primary Outcome Measures
Coronary microvascular resistance results (Combowire)
Estimed by Combowire During coronary angiography, coronary resistance will be measured by pressure and Doppler guides in patients with intermediate coronary stenosis according to the usual procedure.
Correlation between results of Combowire® coronary microvascular resistance and OCTA ophthalmologic findings. A machine learning technique will be used to analyze this series of ocular data and to determine a predictor of post-treatment coronary microvascular resistance.
Coronary microvascular resistance results (OCTA)
Estimated by ophthalmological examinations data from OCTA. An examination of fundus of the eye will then be performed by optical coherence tomography angiography without injection PLEX Elite 9000.
Correlation between results of Combowire® coronary microvascular resistance and OCTA ophthalmologic findings. A machine learning technique will be used to analyze this series of ocular data and to determine a predictor of post-treatment coronary microvascular resistance.
Secondary Outcome Measures
angiographical stenosis
measurement will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
Fractional Flow Reserve (FFR)
measurement of FFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
coronary microvascular resistance (CFR)
measurement of CFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
microvascular resistance values
Microvascular resistances will be measured using (Combowire®). The values of these resistances will be compared between the patient groups according to their cardiovascular risk factor
total area of flow signal void on the choriocapillaris layer
The total area of flow signal void on the choriocapillaris layer will be calculated with help of MATLAB software and will be correlated with cardiovascular risk-factors
Full Information
NCT ID
NCT03739073
First Posted
November 5, 2018
Last Updated
September 21, 2023
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03739073
Brief Title
Can we Predict COronary Resistance By EYE Examination ? (COREYE)
Acronym
COREYE
Official Title
Can we Predict COronary Resistance By EYE Examination ?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 4, 2018 (Actual)
Primary Completion Date
November 3, 2024 (Anticipated)
Study Completion Date
November 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Prospective interventional study, open, non-comparative and non-randomized. The research concerns physiological parameters of the coronary and ocular blood circulation.
At the coronary level, the curves of pressure and Doppler flow will be extracted from ComboMap® (Philips). The coronary microvascular resistances, basal and hyperemic, will be determined by the average ratio of the distal pressure and flow.
At the ocular level, a fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed. The measures of the FFR and the coronary microvascular resistance will be determined by a guidewire allowing measures of pressure and by a guidewire allowing measures of Doppler flow (ComboWire®, Volcano), in 123 patients with intermediate stenosis of the left anterior descending artery (LDA). Topological parameters characterizing the retinal area and choriocapillaries will be determined by statistical approaches and mathematical morphology.
To establish a predictor of the coronary microvascular resistance from the eye vascular parameters, we shall use a non-linear regression by supervised machine learning. The main cardiovascular risk factors (hypertension, diabetes, dyslipidemia, age, sex) will be part of predetermined input features for the machine learning.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
123 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with coronary arterial indication
Arm Type
Experimental
Arm Description
A fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed for patients with intermediate stenosis of the left anterior descending artery (LDA).
Intervention Type
Other
Intervention Name(s)
OCTA (angiography by tomography in optical coherence)
Intervention Description
The study concerns patients with intermediate stenosis of the left anterior descending artery (LDA). A fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed; it's a non-invasive imaging test. OCT uses light waves to take cross-section pictures of your retina and then ophthalmological examination data will correlate with coronary angiography.
Primary Outcome Measure Information:
Title
Coronary microvascular resistance results (Combowire)
Description
Estimed by Combowire During coronary angiography, coronary resistance will be measured by pressure and Doppler guides in patients with intermediate coronary stenosis according to the usual procedure.
Correlation between results of Combowire® coronary microvascular resistance and OCTA ophthalmologic findings. A machine learning technique will be used to analyze this series of ocular data and to determine a predictor of post-treatment coronary microvascular resistance.
Time Frame
Day 1
Title
Coronary microvascular resistance results (OCTA)
Description
Estimated by ophthalmological examinations data from OCTA. An examination of fundus of the eye will then be performed by optical coherence tomography angiography without injection PLEX Elite 9000.
Correlation between results of Combowire® coronary microvascular resistance and OCTA ophthalmologic findings. A machine learning technique will be used to analyze this series of ocular data and to determine a predictor of post-treatment coronary microvascular resistance.
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
angiographical stenosis
Description
measurement will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
Time Frame
Day 1
Title
Fractional Flow Reserve (FFR)
Description
measurement of FFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
Time Frame
Day 1
Title
coronary microvascular resistance (CFR)
Description
measurement of CFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
Time Frame
Day 1
Title
microvascular resistance values
Description
Microvascular resistances will be measured using (Combowire®). The values of these resistances will be compared between the patient groups according to their cardiovascular risk factor
Time Frame
Year 1
Title
total area of flow signal void on the choriocapillaris layer
Description
The total area of flow signal void on the choriocapillaris layer will be calculated with help of MATLAB software and will be correlated with cardiovascular risk-factors
Time Frame
Year 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female patient's ≥18 years of age with coronary arterial indication as usual and with proximal and / or mean IVA stenosis ≥ 50%.
Signed informed consent
Affiliation to the social security system
Exclusion Criteria:
Unstable Coronary Artery Disease
Atrial fibrillation
History of myocardial infarction <6 months in the territory of the proximal and / or mean IVA.
Asthma
Aortocoronary bypass surgery.
Collateral development at the level of the proximal and / or mean IVA.
Allergy to iodine, severe renal insufficiency.
Ametropia> = 6 diopters.
History of retinal ocular pathologies other than uncomplicated diabetic retinopathy and hypertensive retinopathy.
History of ophthalmic treatments such as macular or panretinal laser photocoagulation, intravitreal injection of anti-VEGF or cortisone.
Chronic glaucoma
Patients under guardianship or curators.
Pregnant or lactating women.
Patient's not affiliated to the French social security.
Persons placed under the protection of justice,
Subject participating in another research including an exclusion period still in progress at pre-inclusion
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brahim HARBAOUI
Phone
+33472072696
Email
Brahim.Harbaoui@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fatou LANGEVIN
Email
fatou.langevin@chu-lyon.fr
Facility Information:
Facility Name
Hospices Civils de Lyon - Hopital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brahim Harbaoui
Phone
+33472072696
Email
brahim.harbaoui@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Fatou LANGEVIN
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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