Ultrasonic Markers for Myocardial Fibrosis and Prognosis in Aortic Stenosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Cardiovascular morbidity and mortality
研究概览
简要总结
This study is part of a research project in which new ultrasound-based techniques will be examined to improve clinical decision making for patients with aortic stenosis. These patients could develop increased amounts of myocardial fibrosis. This fibrosis is associated with the patients' prognosis. Fibrosis can be evaluated with magnetic resonance imaging (MRI), which unfortunately is quite expensive and not easily available. Ultrasound-based parameters will be developed for the assessment of the amounts of myocardial fibrosis, especially in the left ventricle. Then it will be examined whether these parameters can predict the patients magnitude of fibrosis and check for association with the patients prognosis. MRI will serve as a gold standard for quantification of myocardial fibrosis. The new echocardiographic techniques and parameters are expected to provide new insights in the interplay between aortic stenosis and left ventricular function, and to ultimately improve the care for patients with aortic stenosis.
The present study's objectives are:
- Quantify the level of myocardial fibrosis in mild, moderate, and severe aortic stenosis compared with a healthy population.
- Evaluate the patients outcome after one and three year of follow-up
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
- Single (Outcomes Assessor)
盲法说明
Analysis will be blinded
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
- 是
入选标准
- •Able to undergo protocolled investigations
- •Patients: Mild, moderate or severe AS
排除标准
- •Renal insufficiency
- •Previously myocardial infarction (ECG, echocardiogram or hospital record)
- •Severe valvular heart disease (except patients)
- •Other cardiac disease known to cause myocardial fibrosis
- •Severe hypertension
- •Other medical conditions deterring protocolled investigation and follow-up
- •Other medical conditions affecting 5-yrs prognosis (cancer, pulmonary disease)
- •Severely reduced image-quality (echocardiography and MRI)
结局指标
主要结局
Cardiovascular morbidity and mortality
时间窗: 1 + 3 year
Admission with heart failure or death caused by cardiac disease ('major adverse cardiac events' MACE)
次要结局
- Time of first re-hospitalisation(3 years)
- All cause mortality(3 years)
- Cardiac systolic function(1 year.)
- Cardiac diastolic function(1 year.)