An observational study in Ventricular Dysfunction, Right, sponsored by Istituto Auxologico Italiano. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Istituto Auxologico Italiano · Observational
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).
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:
Methodology:
Multicenter cross-sectional prospective study of consecutive patients fulfilling the study enrolment criteria, with clinical indication to perform echocardiography and CMR study, with a relatively fair distribution of right ventricular ejection fraction: normal (25%), mildly reduced (25%), moderately reduced (25%) and severely reduced (25%), will be enrolled in each center.
The time interval between echo and CMR studies should be \< 48 h, in the absence of any significant change in clinical status or therapy between the 2 studies.
For echocardiography, 2 sets of acquisitions by 2 different operators will be performed at the beginning and at the end of a routine study (at least 20 min apart). This set will include:
Test-retest measurements will be done independently by the same two operators that acquired the echo images.
For CMR, 2 sets of acquisitions by 2 different technicians including 4-chamber view cine and two sets of short-axis stacks for RV will be acquired at the beginning and at the end of a routine study (at least 20 min apart) after having removed the patient from the scan and his/her repositioning on the table for the second set of acquisitions.
Test-retest measurements will be done independently by two operators analyzing blindly the two acquisitions.
Measurements obtained in each center will be compared with core lab measurements.
Blood pressure and heart rate will be recorded before and at the end of the study.
Demographic, anthropometric and clinical data will be collected.
Based on non-inferiority of 3D right ventricular ejection fraction reproducibility as compared to CMR right ventricular ejection fraction reproducibility (ICC=0.82), the calculated minimal sample size with 5% margin is 183 patients. Taking into account 15% risk of poor quality images or missing value, the sample size was set to at least 215 patients to be enrolled in 6 months.
A minimum of 20 European centers will be invited to collect echocardiography and CMR data from at least 12 subjects/center with a relatively fair distribution of RV ejection fraction by CMR: normal (25%), mildly reduced (25%), moderately reduced (25%) and severely reduced (25%) to be enrolled in 6 months.
90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.
This study's planned enrollment of 215 is above the median of 100 across 51 observational studies indexed under Ventricular Dysfunction, Right.
Browse Ventricular Dysfunction, Right studies →Istituto Auxologico Italiano is the lead sponsor of 202 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive patients fulfilling the study enrolment criteria, with clinical indication to perform echocardiography and CMR study, with a relatively fair distribution of RV ejection fraction: normal (25%), mildly reduced (25%), moderately reduced (25%) and severely reduced (25%)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Right ventricular ejection fraction test-retest reproducibility
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes apart by echocardiography and CMR
Time frame: Through study completion, an average of 6 months
Right ventricular longitudinal strain test-retest reproducibility
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
Time frame: Through study completion, an average of 6 months
Right atrial volume test-retest reproducibility
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
Time frame: Through study completion, an average of 6 months
Tricuspid annulus size test-retest reproducibility
Agreement and intraclass correlation of 2 sets of repeated measurements 20 minutes by echocardiography and CMR
Time frame: Through study completion, an average of 6 months
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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