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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739073
Recruitment Status : Recruiting
First Posted : November 13, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
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 specific guidewire allowing simultaneous measures of pressure and Doppler flow (ComboWire®, Philips), in 200 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Disease Other: OCTA (angiography by tomography in optical coherence) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Can we Predict COronary Resistance By EYE Examination ?
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : April 5, 2020
Estimated Study Completion Date : April 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Patient with coronary arterial indication
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)
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 Measures :
  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 Outcome Measures :
  1. angiographical stenosis [ Time Frame: Day 1 ]
    measurement will be determined by specific guide allowing simultaneous measurements of pressure and spectral Doppler (Combowire®)

  2. Fractional Flow Reserve (FFR) [ Time Frame: Day 1 ]
    measurement of FFR will be determined by specific guide allowing simultaneous measurements of pressure and spectral Doppler (Combowire®)

  3. coronary microvascular resistance (CFR) [ Time Frame: Day 1 ]
    measurement of CFR will be determined by specific guide allowing simultaneous 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739073


Contacts
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Contact: Brahim HARBAOUI +33472072696 Brahim.Harbaoui@chu-lyon.fr
Contact: Fatou LANGEVIN fatou.langevin@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon - Hopital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Brahim Harbaoui    +33472072696    brahim.harbaoui@chu-lyon.fr   
Contact: Fatou LANGEVIN         
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03739073    
Other Study ID Numbers: 69HCL18_0301
2018-A01181-54 ( Other Identifier: ANSM )
First Posted: November 13, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases