Epicardial Measurement of Myocardial Stiffness on Beating Heart and Non-beating Heart During a Programmed Surgical Aortic Valve Replacement for Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
研究概览
简要总结
Elastography is a new non-invasive medical technique for measuring the stiffness at a distance from a tissue. Recent advances in the development of elastography sequences for cardiac exploration suggest a more clinical approach to cardiac elastography. This study propose to compare myocardial stiffness of a group of coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction versus a group of patients who should benefit from a surgical aortic valve replacement for aortic stenosis.
The hypothesis is that the physiological adaptation to pressure overload constituted by aortic stenosis is responsible for a significant increase in myocardial stiffness compared to a reference group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Group I (aortic stenosis):
- •1. Patient undergoing planned surgical aortic valve replacement (SAVR) for aortic stenosis (aortic valve area <1cm² or an aortic valve area index <0.6 cm² / m²);
- •Group II: coronary bypass
- •Patient undergoing planned myocardial revascularization surgery (coronary bypass);
- •Groups I and II
- •Patient over 18 years of age;
- •Patient having read and understood the information letter and having signed the consent form;
- •Patient affiliated or benefiting from a health insurance scheme
排除标准
- •Group II: coronary bypass
- •Ratio in TM mode of the wall thickness over the radius of the left ventricle (h / r [0.45]) confirmed by the TTE;
- •Scar of myocardial infarction defined by an ECG anomaly and / or hypo-akinesia on TTE, and / or a late enhancement in MRI;
- •Acute coronary syndrome less than 3 months old;
- •Significant aortic stenosis (Vmax> 1.5 m / s);
- •Anomaly of segmental kinetics;
- •Presence of left ventricular hypertrophy
- •Groups I and II
- •Mitral valve disease (> 1/4 confirmed by TTE);
- •Aortic insufficiency (> 1/4 confirmed by TTE);
- •Left ventricle ejection fraction (LVEF) <50% confirmed by TTE;
- •Hospitalization for heart failure less than 3 months old;
- •Urgent surgery;
- •Infiltrative heart disease;
- •Hostile pericardium defined by a history of mediastinal radiotherapy, tamponade or complicated pericarditis;
- •Decompensated or severe arterial hypertension.
- •Functional inability to walk preventing the performance of the walk test;
- •Proven pregnant woman (positive urine pregnancy test) or breastfeeding or absence of effective contraception (as defined by the WHO) or postmenopausal woman without confirmation diagnosis obtained (amenorrhea not medically induced for at least 12 months before the initiation visit) ;
- •Person deprived of their liberty by an administrative or judicial decision or person placed under the protection of justice / guardianship or curatorship
- •History of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participating in the protocol or preventing him from giving his informed consent
研究组 & 干预措施
Surgical Aortic Valve Replacement
Patients with aortic stenosis
干预措施: Aixplorer Mach30 (Device)
Reference
Coronary bypass patients without hypertrophic left ventricular remodeling or sequelae of myocardial infarction
干预措施: Aixplorer Mach30 (Device)
结局指标
主要结局
to compare myocardial stiffness by ShearWave elastography on not beating heart in two groups of patients referred for surgery
时间窗: Day 1
The main outcome measure is evaluated by ShearWave elastography with the measurement of Young modulus on non-beating heart
次要结局
- To compare the diastolic myocardial stiffness of the beating heart with the myocardial stiffness of the non-beating heart(Day 1)
- Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with heart failure parameters(Day 1)
- Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with conventional diastolic indices(Day 1)
- Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart with left ventricular mass indexed to the body surface(Day 1)
- Correlation between the diastolic myocardial stiffness of the beating heart and the non-beating heart and the prognosis(1 year)
- To compare epicardial and trans-thoracic diastolic myocardial stiffness(Day 1)