Test Retest Reproducibility of Right heArt Parameters by Echocardiography and Cardiac Magnetic Resonance (EACVI TERRA Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 215
- 主要终点
- Tricuspid annulus size test-retest reproducibility
研究概览
简要总结
The reliability of advanced echocardiographic and cardiac magnetic resonance (CMR) parameters at repeated measurements is not fully clarified. Test-retest reliability of measurements is crucial for follow-up studies and for clinical monitoring of patients to detect a significant change in ventricular performance, as well as to assess the outcome of various therapies on the size and function of cardiac structures. For echocardiography, the variability of the measurement is more complex, as it depends both on acquisition and reading variability, but also closer to the real life setting than observer variability. Much more limited data exist on the test-retest reliability of right heart parameters, i.e. right ventricle (RV), right atrial (RA) and tricuspid annulus (TA) parameters than on their observer variability and than of the equivalent left-sided parameters.
The primary aim of the study is to compare the test-retest reproducibility and agreement of advanced echocardiographic parameters of RV and RA size and function, and of tricuspid annulus (TA) size against the respective parameters obtained by conventional echocardiography and by CMR (where applicable).
详细描述
Right ventricular (RV) size and function play a crucial role in determining patient functional status and prognosis in various conditions. The quantification of RV dimensions and function is part of any routine imaging workup involving echocardiography and cardiac magnetic resonance. Complex clinical decision-making, such as to select candidates for various interventions (repair procedures for treating tricuspid regurgitation, ventricular assist devices, etc) and imaging follow-up to identify the optimal timing for intervention require an accurate and reproducible approach to RV evaluation. However, due to its complex shape, thin and highly trabeculated wall, the RV is more challenging and technically difficult to evaluate in comparison to the left ventricle (LV). In the last years, RV strain by speckle-tracking echocardiography (STE) and ejection fraction by three-dimensional (3D) echocardiography emerged as superior metrics of RV systolic performance, overcoming some of the limitations of conventional echocardiographic parameters. To date, cardiac magnetic resonance (CMR) has been considered the gold standard for the assessment of RV volumes and ejection fraction. More recently, RV strain as a more sensitive and less load-dependent metric of RV performance than ejection fraction can be quantified by CMR feature tracking, yet its clinical value remains to be demonstrated.
The reliability of advanced echocardiographic and CMR parameters at repeated measurements is not fully clarified. For echocardiography, the variability of the measurement is more complex, as it depends both on acquisition and reading variability, but also closer to the real life setting than observer variability. Much more limited data exist on the test-retest reliability of RV, right atrial (RA) and tricuspid annulus (TA) parameters than on their observer variability and than of the equivalent left-sided parameters. Test-retest reliability of measurements is crucial for follow-up studies and for clinical monitoring of patients to detect a significant change in ventricular performance, as well as to assess the outcome of various therapies on tricuspid valve (TV) and RV size and function.
The investigators aim to explore in a multicenter setting the test-retest reproducibility of RV and RA size and function, and of tricuspid annulus (TA) size by echocardiography and CMR.
The primary aim of the study is to compare the test-retest reproducibility and agreement of advanced echocardiographic parameters of RV and RA size and function, and of tricuspid annulus (TA) size against the respective parameters obtained by conventional echocardiography and by CMR (where applicable).
Secondary aims:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Age over 18 years old
- •Informed consent
排除标准
- •Age <18 years old
- •Pregnancy/breast feeding
- •Tricuspid valve repair/prosthesis
- •Pacemaker or implantable cardiac defibrillator
- •Complex congenital diseases (exceptions: bicuspid aortic valve, atrial septal defect, ventricular septal defect, corrected tetralogy of Fallot)
- •Poor acoustic window
- •Inability to acquire 3D datasets with at least 20 volumes/s
- •Very irregular R-R interval
- •Claustrophobia
- •Acute conditions
- •Hemodynamically instable patients
- •Patients who do not provide consent for the study protocol
结局指标
主要结局
Tricuspid annulus size test-retest reproducibility
时间窗: Through study completion, an average of 6 months
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
Right ventricular ejection fraction test-retest reproducibility
时间窗: Through study completion, an average of 6 months
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes apart by echocardiography and CMR
Right ventricular longitudinal strain test-retest reproducibility
时间窗: Through study completion, an average of 6 months
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
Right atrial volume test-retest reproducibility
时间窗: Through study completion, an average of 6 months
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
次要结局
未报告次要终点
