跳至主要内容
临床试验/NCT06193655
NCT06193655尚未招募不适用

Test Retest Reproducibility of Right heArt Parameters by Echocardiography and Cardiac Magnetic Resonance (EACVI TERRA Study)

Istituto Auxologico Italiano0 个研究点目标入组 215 人开始时间: 2024年1月最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

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