Can we Predict COronary Resistance By EYE Examination ? (COREYE)

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: OCTA (angiography by tomography in optical coherence)

• Registration Number: NCT03739073
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-04
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-09
• Study First Posted: 2018-11-13
• Primary Completion: 2024-03-20
• Study Completion: 2024-03-20
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Male and female patient's ≥18 years of age with coronary arterial indication as usual and with proximal and / or mean IVA stenosis ≥ 50%.
2. Signed informed consent
3. Affiliation to the social security system

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Exclusion Criteria

1. Unstable Coronary Artery Disease
2. Atrial fibrillation
3. History of myocardial infarction <6 months in the territory of the proximal and / or mean IVA.
4. Asthma
5. Aortocoronary bypass surgery.
6. Collateral development at the level of the proximal and / or mean IVA.
7. Allergy to iodine, severe renal insufficiency.
8. Ametropia> = 6 diopters.
9. History of retinal ocular pathologies other than uncomplicated diabetic retinopathy and hypertensive retinopathy.
10. History of ophthalmic treatments such as macular or panretinal laser photocoagulation, intravitreal injection of anti-VEGF or cortisone.
11. Chronic glaucoma
12. Patients under guardianship or curators.
13. Pregnant or lactating women.
14. Patient's not affiliated to the French social security.
15. Persons placed under the protection of justice,
16. Subject participating in another research including an exclusion period still in progress at pre-inclusion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with coronary arterial indication	OCTA (angiography by tomography in optical coherence)	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).

Primary Outcome Measures

Name	Time	Method
Coronary microvascular resistance results (Combowire)	Day 1	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)	Day 1	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

Name	Time	Method
Fractional Flow Reserve (FFR)	Day 1	measurement of FFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
microvascular resistance values	Year 1	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	Year 1	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
angiographical stenosis	Day 1	measurement will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)
coronary microvascular resistance (CFR)	Day 1	measurement of CFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)

Trial Locations

Locations (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse; 🇫🇷 Lyon, France