NCT02551588已完成不适用
Calcified Aortic Valve Stenosis (AVS). Markers of Fibrosis Using Cardiac Magnetic Resonance
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- prevalence of myocardial fibrosis in MRI in patients with AVS
研究概览
简要总结
Aortic valve stenosis (AVS) is the most frequent valvular disease. The severity of the obstruction of the left ventricle (LV) is essentially analyzed today by echocardiography Doppler, which assesses two key markers that are aortic valve pressure gradient and the aortic valve area. however these marker are a poor reflect of the clinical severity of AVS. The aim of the study is to validate new markers assessing cardiac fibrosis that might best or complementary markers.
详细描述
To validate new markers assessing cardiac fibrosis three groups of subjects were studied in controls subjects and patients with AVS in order to :
- Analyze myocardial fibrosis markers in MRI, the degree of hypertrophy, remodeling and wall shear stress in a control population and in three groups of subjects to RA progressively increasing risk: asymptomatic subjects without symptomatic subjects LV dysfunction, symptomatic patients with LV dysfunction. The factors favoring the appearance of fibrosis observed in MRI will be analyzed on all subjects.
- To validate these fibrosis markers estimated by MRI by histological analysis of biopsies performed in patients undergoing aortic valve replacement.
- Monitoring compliance with the distribution of markers of fibrosis and wall stress estimated on Initial MRI are factors of aggravation or not improved function and / or remodeling remote myocardial. Public hospitals in Paris
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Echocardiography considered as normal and / or age-related
- •Patients who have received prior clinical examination
- •Patient receiving a social security scheme or entitled, or CMU
- •After having giving written informed consent.
- •Patients symptomatic with indication of surgery (group surgery) or not
排除标准
- •With one of the following cardiac abnormalities: atrial fibrillation, more than moderate either aortic or mitral valve regurgitation
- •Heart valve surgery history (aortic, mitral, tricuspid and pulmonary).
- •Indication for cardiac surgery other than on the aortic valve.
- •Usual counter-indications of MRI: Pace-maker, defibrillator, metallic objects including gadolinium allergy.
- •Patients with severe renal insufficiency with a clearance <30 ml / min estimated by the Cockcroft & Gault formula.
- •Patient who cannot be followed over the duration of a year.
- •CONTROLS (healthy volunteers)
- •Inclusion criteria:
- •Normal EKG
- •Echocardiography considered normal and / or age-related
- •Patients who have received prior clinical examination
- •Patient receiving a french national social security
- •After having obtain written informed consent.
- •Criteria for non-inclusion
- •History of known or detectable infarction on EKG
- •Known primary or secondary cardiomyopathy or detectable on echocardiography
- •Thoracic radiotherapy or chemotherapy history
- •Subject with usual contra-indications of MRI: claustrophobia, metallic objects.
- •Patients with significant renal insufficiency with a clearance <90 ml / min estimated by the Cockcroft & Gault formula.
- •Subject who could be planned for 2 CMR within two weeks
结局指标
主要结局
prevalence of myocardial fibrosis in MRI in patients with AVS
时间窗: At one year
Indices of myocardial fibrosis will been analysed as combined criteria to analyse myocardial fibrosis
次要结局
- Correlation with Doppler Echocardiography Assessment, and wall stress estimate by using both cardiac MR and carotid artery pressure (applanation tonometry)(At inclusion and at one year)
- comparison of these markers with myocardial histology(At inclusion and at one year)
研究者
研究点 (1)
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