Echocardiography

Researchers are conducting a multi-center clinical study to assess artificial intelligence (AI) algorithms for measuring heart function and size using echocardiography. The study aims to compare AI measurements with those of physicians at different experience levels, evaluate the accuracy and stability of AI, and explore its use in complex heart conditions like cardiomyopathy, valve disease, and coronary heart disease. The goal is to improve diagnostic consistency and clinical workflows across medical centers. The study involves measuring cardiac chamber size and function in 1600 participants using AI, senior physicians, and intermediate physicians. All measurements are made with Mindray ultrasonic machines. AI and intermediate physician results are completed within one day after data collection, while senior physician results are completed within one month. The study will establish a standardized reference system for AI-assisted echocardiographic measurements and evaluate AI's performance in special cases. Participants will undergo echocardiographic scans with measurements of left and right ventricular size and function, Doppler ultrasound indicators, and valve annulus displacements. Researchers will analyze data to compare AI and physician measurements, assess measurement deviations, and evaluate AI's efficiency in reducing analysis time. The study will run until July 2026, with ongoing data collection and analysis across multiple centers, aiming to promote wider clinical application of AI technology for cardiovascular disease diagnosis.

This research aims to evaluate Bevonescein, a sterile intravenous drug, in patients undergoing minimally invasive abdominopelvic surgery. The study focuses on assessing the safety, tolerability, and effectiveness of Bevonescein in highlighting nerves and ureters during surgery. It also investigates how the drug behaves in the body and the dose needed to produce clear fluorescent imaging for nerve and ureter visualization. Participants will receive Bevonescein during two study phases: a dose defining phase and a dose expansion phase for each surgical setting. The drug is given as an intravenous infusion, and the study uses specialized imaging systems to record fluorescence signals in targeted tissues. These phases help determine the optimal dose and gather safety and imaging data. Throughout the study, participants will be monitored with fluorescence system surveys approximately 28 days after dosing, plus or minus 5 days. Researchers will collect data on the drug's imaging effects and safety. The total duration includes screening, dosing, and follow-up assessments to evaluate Bevonescein’s performance during minimally invasive surgery.

Researchers are evaluating a new noninvasive system that uses artificial intelligence (AI) to analyze multiple types of imaging, including magnetic resonance enterography (MRE) and computed tomography enterography (CTE), to help diagnose and predict outcomes for digestive diseases. This observational study collects and analyzes retrospective imaging, endoscopic, and clinical data from 21 centers in China to build and improve the AI model. The model will then be tested prospectively in two centers and its ability to locate lesions will be checked in real-world endoscopy settings. The study involves using a virtual endoscopy model to assist in diagnosis by integrating and analyzing multimodal imaging features. The AI system is designed to support diagnosis without any invasive procedures. The study will confirm the model's accuracy and effectiveness through retrospective data, prospective validation, and real-world deployment in clinical environments. Participants will contribute data from their imaging and endoscopic exams, with at least one technically adequate CT or MR scan and a high-quality colonoscopy performed within one month of imaging. Researchers will assess the AI model's diagnostic performance by measuring the area under the ROC curve (AUC) over six months. The study includes ongoing monitoring of data quality and imaging accuracy to ensure reliable validation of the AI system.

Researchers are studying how to improve the accuracy of echocardiographic reports by making them more consistent with current international guidelines and reducing diagnostic errors. This observational study focuses on whether adding automated diagnostic algorithms can help enhance the overall quality of these reports. The study is sponsored by Istituto Auxologico Italiano and aims to address important questions about diagnostic consistency during echocardiographic analysis. The study involves modifying the existing COMPACS software to include several guideline-based algorithms designed to assist clinicians in reducing diagnostic mistakes and better following clinical guidelines. This software device will be evaluated during the analysis of echocardiographic data to see if it improves diagnostic accuracy. Participants in the study have undergone clinically-indicated echocardiographic exams. Researchers will assess inconsistencies between quantitative and qualitative report parameters, as well as differences between clinical diagnoses and guideline recommendations. This will be done through analysis of the echocardiographic data collected. The study may continue until September 2026, with no additional interventions required from participants beyond data use.

Diabetes is a widespread chronic condition that leads to high risks of cardiovascular problems and lower limb amputations. This research explores how Spatial Frequency Domain Imaging (SFDI), a noninvasive optical method, can assess blood flow changes before and after lower limb revascularization procedures like angioplasty in diabetic patients. The trial aims to determine if SFDI can provide objective feedback to predict outcomes and aid early intervention to save limbs. Participants will undergo SFDI imaging on both the treated and untreated feet, focusing on the heel and pad areas. Imaging is done before and after the angioplasty procedure on the same day to capture changes in tissue oxygen saturation and hemoglobin. This pilot study involves 15 diabetic patients having lower limb arterial angioplasty. During the study, participants will have noninvasive foot assessments using SFDI to monitor tissue oxygen levels and blood flow. Researchers will compare these imaging results with toe pressure measurements to evaluate changes in perfusion caused by angioplasty. The primary measure is the change in tissue oxygen saturation immediately before and after the procedure. The overall participation lasts around the intervention day with imaging assessments pre- and post-operation.

Septic shock is a life-threatening condition with high mortality rates. Researchers are studying how left and right atrial strain (LAS and RAS) measurements, obtained through speckle tracking echocardiography, can help evaluate heart function in these patients. This observational study focuses on comparing two echocardiographic software programs, ECHOPAC and UWS, to understand differences in their LAS and RAS measurements, and to test a new AutoStrain technology for measurement reproducibility among observers. The study uses retrospective data from adult patients treated for septic shock who had transthoracic echocardiography (TTE) as part of their care. It compares variations in several atrial strain measurements between the two software tools, including analyses from different heart views and measurement modes. The study also assesses how consistent the measurements are when performed manually or with AutoStrain, across different observers. Participants are adults over 18 treated for septic shock with available echocardiographic data. Researchers review existing echocardiograms and collect various atrial strain measurements over one year. They evaluate measurement differences, reproducibility, and the effectiveness of AutoStrain technology. This non-interventional study involves no new treatments or procedures and will contribute to improving heart function assessment in critically ill patients.

This research aims to explore a new way to assess if patients are ready for surgery, focusing on those with gastric, oesophageal, or pancreatic cancer. Surgery for these cancers is very demanding, so doctors need reliable methods to predict if a patient can handle the procedure. Currently, fitness is tested using Cardiopulmonary Exercise Tests (CPET), which involve cycling with increasing effort to measure oxygen use. However, CPET can be hard for some patients and requires many resources. This study investigates whether Magnetic Resonance Spectroscopy (MRS) of thigh muscle fat levels can serve as an alternative measure of surgical fitness. The study has two phases. In the first phase, 56 patients scheduled for major cancer surgeries will have MRS scans of their thigh muscles along with their usual CPET tests. The MRS scans will be done without delaying their treatment and can be scheduled within two weeks of referral. In the second phase, 25 healthy volunteers will have repeated MRS scans in a single session and again after two weeks to check the consistency of MRS measurements over time. Participants will undergo MRS scans, and for patients also CPET, with no changes to their normal treatment schedule. Researchers will compare the fat levels from MRS scans with CPET results to see if they correlate well. They will also study differences between patients who experience major complications and those who do not, and assess the repeatability of MRS results over short and long periods. The study will last up to two years to collect and analyze these outcomes.

Researchers are investigating new diagnostic and prognostic markers for cardiomyopathy (CMP) to better predict how the disease progresses, especially toward heart failure or the need for heart transplantation. The study focuses on microRNAs and spatial transcriptomics, promising techniques that may reveal important disease mechanisms. Patients with various types of CMP, including hypertrophic, dilated, arrhythmogenic, and forms related to amyloidosis and Fabry disease, are being evaluated to improve diagnosis and management. This observational study has both retrospective and prospective parts. Retrospective data from patients treated since 1990 will be collected from medical records, while prospective patients are enrolled from outpatient or inpatient settings at several medical centers. Patients undergo standard clinical tests such as ECG, echocardiograms, cardiac magnetic resonance (CMR), biopsies, and genetic testing. Additional molecular analyses on blood plasma and cardiac tissue will be done for some prospective patients. Tissue samples collected during routine biopsies or surgeries will be processed for advanced RNA analyses. Participants will provide informed consent and be evaluated according to clinical needs without a set minimum follow-up time. Data collected include demographics, medical and family history, symptoms, treatments, and genetic information. Researchers will use this information to identify new biomarkers related to CMP diagnosis and prognosis. The main outcome focuses on risk stratification over a follow-up of two years after a 30-month enrollment period, with data analysis lasting six months. Molecular studies of gene expression and microRNAs will also be analyzed during this time.

This research aims to evaluate the clinical performance of the Vivid Pioneer Diagnostic Ultrasound System in adults who need transesophageal echocardiography (TEE) as part of their medical care. The study focuses on assessing the quality, usability, safety, and stability of this investigational ultrasound device compared to existing commercial cardiac ultrasound systems. It is an observational study sponsored by GE Healthcare, designed to support current clinical standards without affecting patient treatment timing. Participants will first undergo transthoracic echocardiography (TTE) using the investigational device. Then, after being anesthetized, they will receive the standard transesophageal echocardiography (TEE) procedure. Following the investigational device scan, the probe will be switched to a commercial ultrasound device for intraoperative guidance to ensure no delay in diagnosis or treatment. Researchers will evaluate the system's overall operation, image quality, user interface, workflow, and safety. During the study, investigators will complete a user feedback questionnaire covering the device's performance and functionality. Outcome measures include system operation, reliability, operability, and image quality, rated on a five-grade scale from Excellent to Very Bad. The study period extends from enrollment through the first day of scanning. Participants will be monitored for device safety and stability throughout their involvement, which lasts up to one day post-enrollment.

Atrial fibrillation (AF) is a common irregular and often fast heart rhythm affecting adults worldwide, with increasing incidence and prevalence. It is linked to higher health risks and other conditions like hypertension and diabetes, impacting patients and healthcare systems. The European Society of Cardiology recommends an integrated care model that includes catheter ablation to manage symptoms and physical activity to improve health, but the effects of exercise after ablation are not well established. This randomized controlled trial aims to study how a 12-week physical exercise program influences patients who underwent catheter ablation for AF at least one year ago. Participants will be randomly assigned to either an exercise group, which will do concurrent strength and aerobic training three times a week with progressively increasing duration and intensity, or a control group receiving usual care without intervention. The exercise sessions include warm-up, resistance training with free weights, aerobic training on a cycle ergometer, and cool-down stretches. Participants will be evaluated three times: before the intervention, after three months of training, and six months after recruitment to assess lasting effects. Assessments include body composition, ECG, echocardiogram, physical activity monitoring, sleep analysis, muscle strength, cardiorespiratory capacity, quality of life, and AF burden. Attendance at exercise sessions will be recorded to monitor adherence, and safety insurance covers potential risks during training and evaluations.