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

NCT03739073 | Completed

• 2 other identifiers: 69HCL18_03012018-A01181-54
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 1

• 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.

  Day 1

Secondary Outcomes (5)

• angiographical stenosis

  Day 1

• Fractional Flow Reserve (FFR)

  Day 1

• coronary microvascular resistance (CFR)

  Day 1

• microvascular resistance values

  Year 1

• total area of flow signal void on the choriocapillaris layer

  Year 1

Study Arms (1)

Patient with coronary arterial indication

EXPERIMENTAL

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).

Other: OCTA (angiography by tomography in optical coherence)

Interventions

OCTA (angiography by tomography in optical coherence) OTHER

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.

Patient with coronary arterial indication

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Location

Related Publications (1)

• Harbaoui, B. (2021). Arterial stiffness, physiology, and relevance of interventional cardiology procedures (Habilitation à diriger des recherches thesis). Université Claude Bernard Lyon 1. (Manuscript hosted by CREATIS/INSA Lyon; defense notice by Lyon 1).

  RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 13, 2018
• Study Start: October 4, 2018
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: December 19, 2025

Record last verified: 2025-12

Locations

FR (1)