Can we Predict COronary Resistance By EYE Examination ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Coronary microvascular resistance results (Combowire)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unstable Coronary Artery Disease
- •Atrial fibrillation
- •History of myocardial infarction <6 months in the territory of the proximal and / or mean IVA.
- •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
结局指标
主要结局
Coronary microvascular resistance results (Combowire)
时间窗: 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)
时间窗: 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.
次要结局
- Fractional Flow Reserve (FFR)(Day 1)
- microvascular resistance values(Year 1)
- total area of flow signal void on the choriocapillaris layer(Year 1)
- angiographical stenosis(Day 1)
- coronary microvascular resistance (CFR)(Day 1)