US Benchmarking Clinical Study

This is a multicenter, prospective, consecutive cross-sectional study with three parallel arms and non-competitive enrollment. The study is designed to advance the clinical understanding of myocardial and hepatic stiffness by using a novel ultrasound elastography device, the eMyosound LYRA. The prospective design is essential because this elastographic assessment is not yet part of standard care, and the investigational device is being made available specifically for this research. Consecutive recruitment will be used to minimize selection bias by inviting all eligible patients to participate. The cross-sectional design means that no longitudinal follow-up?follow-up The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes. visits are required, making the study feasible for a single-visit assessment. The primary objective?primary objective The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected. is to determine the shear wave velocity (SWV) in the left ventricle, right ventricle, and liver of three distinct patient populations as specified in the Groups and Interventions section of this form. The study also aims to establish the device's proportion of patients in whom SWV can be estimated, to characterize the distribution of various myocardial and hepatic SWV measurements, and to compare these distributions between the three study arms. We will also investigate the statistical associations between SWV and a range of clinical, ECG?ECG A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged., laboratory, and echocardiographic variables to better understand how these parameters correlate with myocardial stiffness. A key part of our methodology involves a test-retest procedure with two independent observers to establish the within-observer repeatability and between-observer reliability of the SWV measurements. Study Conduct and Procedures The study will enroll a total of 150 analyzable participants (50 per arm) from three medical centers. The total enrollment may reach up to 180 to account for potential dropouts or non-contributing data. The study is confined to a single visit for each participant, with a total estimated duration of 2.5 hours. At the single visit, after informed consent is signed, patients will undergo a series of assessments. A standard medical history and physical examination will be performed. Patients will also receive a 12-lead ECG, blood work (including NT-proBNP and hsTnT), and a standard echocardiogram with a wide range of measurements. Following these standard cardiology assessments, the investigational elastographic assessment will be performed with the eMyosound LYRA device, a Class II medical device for real-time sonographic imaging, shear wave measurement, and electrocardiographic recording. The assessment includes two types of shear wave measurements using the device's M3-5 LYRA probe: Myocardial Shear Wave Velocity (SWV): Measurements will be taken in specific myocardial regions of interest (ROIs), including the right ventricular anterior free wall (RVAW), left ventricular anteroseptal wall (LVAW), and interventricular septum (IVS). These measurements are acquired in both parasternal long-axis (PLAX) and parasternal short-axis (PSAX) views, and the IVS is also measured in the apical 4-chamber (A4C) view. Hepatic Shear Wave Velocity (SWV): The operator will measure SWV in two distinct ROIs of the liver's right lobe. The types of measurements include Acoustic Radiation Force Induced Shear Waves (ARF-SWV), which are performed during diastasis, and Natural Shear Waves (N-SWV), which are produced by cardiac movements. For the test-retest procedure, each of the two observers will attempt to acquire 20 repeated valid measurements for each target ROI. Risk and Safety Management The study is designed to minimize risks, which are similar to those of other echocardiographic devices. Risk management is handled by respecting the device's indications and contraindications?contraindications A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan. and providing detailed training and technical support to investigators. The potential benefit to participants is a free, thorough cardiological assessment. A Data and Safety Monitoring Board (DSMB) will provide independent oversight, review all adverse events?adverse events Any unwanted medical problem that happens during a study, whether or not it was caused by the treatment. A 'serious' adverse event is one that meets specific criteria, such as causing death, being life-threatening, requiring or prolonging hospital admission, causing significant disability, or another medically important outcome., and make recommendations to the sponsor?sponsor The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.. Statistical Analysis The study is primarily descriptive and exploratory. The target sample size is 150 analyzable patients. The final analysis will be performed once all participants have completed the study. Two interim analyses are planned: a qualitative analysis after the first 15 patients to check for safety issues and a quantitative analysis after the first 75 patients to check data quality.