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

Coronary Artery Disease Clinical Trial

— COREYE  

Official title:

Can we Predict COronary Resistance By EYE Examination ?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739073
• Other study ID #: 69HCL18_0301
• Secondary ID: 2018-A01181-54
• Status: Completed
• Phase: N/A
• Start date: October 4, 2018
• Est. completion date: March 20, 2024

Study information

• Verified date: April 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: March 20, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Other:
• OCTA (angiography by tomography in optical coherence)
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.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hopital de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	angiographical stenosis	measurement will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)	Day 1
Secondary	Fractional Flow Reserve (FFR)	measurement of FFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)	Day 1
Secondary	coronary microvascular resistance (CFR)	measurement of CFR will be determined by guide allowing measurements of pressure and spectral Doppler (Combowire®)	Day 1
Secondary	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	Year 1
Secondary	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	Year 1