Myocardial Fibrosis With High Frame Rate Echocardiography in Patients With Aortic Stenosis - A Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cardiovascular morbidity
研究概览
简要总结
This study is a long term follow-up of patients that were included as part of a previous study (NCT03422770), where patients with aortic stenosis and healthy controls went through echocardiography, cardiac MRI, long-term ECG-recording, blood tests and quality of life assessment. Echocardiography included high frame ultrasound for detection of natural mechanical waves, and the measured speed of these waves were used as a marker of the extent of myocardial fibrosis.
Up to five years have now passed since inclusion at baseline, and a proportion of the patients in the cohort have undergone aortic valve replacement at some point. In this study, the investigators will repeat the cardiac imaging (echocardiography and cardiac MRI), ECG and blood test, to assess long-term changes in myocardial fibrosis in aortic stenosis patients.
详细描述
High frame rate ultrasound with quantification of myocardial mechanical wave velocities provides a new approach to evaluation of myocardial stiffness.
Principle: An elastic medium (the left ventricle) is incited by a force (naturally occuring mechanical wave generated by atrial contraction and/or closure of mitral and aortic valve), and the resulting oscillation wave propagates through the medium with a speed that depends only on the density and stiffness of the medium. If the density of the medium is known, measuring the propagation velocity of the wave is the same as measuring the stiffness of the medium.
There is a lack of longitudinal data in this research area. A follow-up study of the described cohort, will add valuable insight into high frame rate ultrasound as a potential tool to quantify myocardial fibrosis in heart failure patient, and to monitor any changes from baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Part of the initial cohort that were included in the baseline study
- •Still 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-years prognosis (cancer, pulmonary disease)
- •Severely reduced image-quality (echocardiography and MRI)
结局指标
主要结局
Cardiovascular morbidity
时间窗: 5 year
Admissions with heart failure
Cardiovascular mortality
时间窗: 5 year
Death caused by cardiac disease
次要结局
- Cardiac diastolic function (5 of 5)(5 years)
- Cardiac diastolic function (1 of 5)(5 years)
- All cause mortality(5 years)
- Cardiac diastolic function (2 of 5)(5 years)
- Cardiac diastolic function (3 of 5)(5 years)
- Cardiac systolic function(5 years)
- Velocity of natural mechanical waves propagating through the myocardium(5 years)
- Time of first re-hospitalization(5 years)
- Cardiac diastolic function (4 of 5)(5 years)