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Completed

NCT Number: NCT03739073

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de Lyon - Hopital de la Croix Rousse

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Coronary microvascular resistance results (Combowire)

    Time frame: 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.

  2. Coronary microvascular resistance results (OCTA)

    Time frame: 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 outcomes

  1. angiographical stenosis

    Time frame: Day 1

    measurement will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)

  2. Fractional Flow Reserve (FFR)

    Time frame: Day 1

    measurement of FFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)

  3. coronary microvascular resistance (CFR)

    Time frame: Day 1

    measurement of CFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)

  4. microvascular resistance values

    Time frame: 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

  5. total area of flow signal void on the choriocapillaris layer

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Can we Predict COronary Resistance By EYE Examination ?

Acronym: COREYE

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2018
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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