Clinical Research Directory

Long-term Outcomes After Percutaneous Closure of PFO

International medical centre Medicor from Slovenia has reported 363 successful percutaneous closures of patent foramen ovale (PFO) from October 2006 till October 2023. The investigators are going to follow-up the participants clinically and with contrast transthoracic echocardiography (TTE) to define the percentage of functional percutaneous closure.

Mitral Doppler as a Predictor of Respiratory Worsening After Vascular Filling

Interventional study of the accuracy of a non-invasive testing by echocardiography to predict respiratory worsening after vascular filling.

The Use of Single-Beat TE-e' in Evaluation of Left Atrial Pressure in Critically Ill Patients: The TELAP-ICU Trial

This study evaluates a new single-beat echocardiographic technique (TE-e', the time difference between the onset of the mitral inflow E wave and the septal e' wave on tissue Doppler imaging) for estimating left atrial pressure (LAP) in critically ill patients, comparing it against the standard two-beat method. The goal is to determine whether the faster, single-beat method gives results as reliable as the conventional method, and whether it can help identify patients with elevated left atrial pressure without an invasive procedure.

Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Patients With Pulmonary Arterial Hypertension PAH

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

Assessment of Total Pulmonary Resistance sPAP/CO Between High Altitude HA vs. Sea Level LA in Healthy Individuals H

To study the effect of relocation from high altitude (Quito Ecuador: 2850m) to sea level on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in healthy individuals, who live permanently \>2600m.

Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Healthy Individuals

To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in healthy individuals, who live permanently \>2600m.

Assessment of Total Pulmonary Resistance sPAP/CO Between Sea Level LA vs. High Altitude HA After Re-ascent in Patients With Pulmonary Arterial Hypertension PAH

To study the effect of a re-ascent after a one-week stay at sea level (after prior descent from 2850m) to high altitude (Quito Ecuador: 2850m) on pulmonary resistance (sPAP/CO) and other hemodynamic outcomes in patients with pulmonary arterial hypertension PAH, who live permanently \>2600m.

Federated Learning for Point-of-Care Cardiac Ultrasound

This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations. Federated learning allows participating clinical sites to contribute to model development while keeping raw ultrasound images and directly identifiable patient information within each site's controlled computing environment. Encrypted model updates, rather than patient images, will be transmitted for secure aggregation. The prospective validation cohort will include approximately 3,000 adults undergoing clinically indicated focused cardiac ultrasound. Model performance will be compared with an expert interpretation of a comprehensive transthoracic echocardiogram performed within 24 hours. The primary objective is to determine how accurately the model identifies reduced left ventricular systolic function, defined as a left ventricular ejection fraction below 40%. During the initial validation period, the investigational software will operate in silent mode. Its results will not be displayed to treating clinicians and will not be used to diagnose participants, select treatment, or replace standard clinical interpretation. The study will also evaluate image-quality classification, cardiac-view recognition, performance across clinical sites and ultrasound systems, model calibration, processing time, cybersecurity, privacy resilience, and performance across demographic and clinical subgroups. Long-term monitoring will assess whether model performance changes as clinical populations, ultrasound equipment, acquisition practices, and software environments evolve during the 2026-2037 study period.

Effects of Pulmonary Resection on Right Ventricular Function

Lung resection is associated with high postoperative morbidity and mortality and leads to a significant long-term decrease in functional capacity, particularly due to cardiorespiratory complications. One of the contributing factors to this functional decline is the postoperative reduction in right ventricular function. Due to the anatomical proximity and interactions, right ventricular function is evaluated by echocardiography following lung resection. The pulmonary artery pressure (PAP)/tricuspid annular plane systolic excursion (TAPSE) ratio is a parameter that provides a more comprehensive assessment of right heart function by evaluating both right ventricular systolic function and pulmonary artery pressure. In this study, investigators aimed to evaluate changes in right heart function by performing preoperative and postoperative echocardiographic assessments in participants undergoing lung resection, focusing on PAP/TAPSE ratios.

Acute Cardiac Effects of Ultra-Trail Running

This prospective observational study aims to investigate the acute cardiovascular effects of ultra-endurance running using comprehensive echocardiographic assessment combined with biological analyses. The main hypothesis is that participation in an ultra-trail race induces acute and transient changes in cardiac function involving both the left and right ventricles, associated with elevations in cardiac biomarkers, with physiological responses varying according to race distance and training level and showing spontaneous recovery within the days following the event. Adult amateur runners participating in ultra-trail races of 80 km or 160 km will undergo standardized clinical evaluation, electrocardiography, and transthoracic echocardiography with myocardial deformation analysis at multiple time points, including baseline, pre-effort, during the race, immediately after exercise, and during early recovery approximately one week after the event. Biological sampling will be performed before the race, immediately after exercise, and at follow-up. The primary objective is to evaluate acute changes in left ventricular systolic function assessed by global longitudinal strain. Secondary objectives include the assessment of biventricular and atrial function, cardiac and non-cardiac biomarkers, recovery patterns after ultra-endurance exercise, and the influence of race distance, training level, performance level, and sex on cardiovascular responses. This exploratory single-center study conducted in France seeks to provide an integrative characterization of cardiac adaptations to extreme endurance exercise and to generate physiological insights that may guide future research and cardiovascular monitoring strategies in endurance athletes.

Diagnostic Accuracy of a Deep Learning-Based Software for Automated Multiparametric Echocardiographic Measurements

Transthoracic echocardiography is an essential imaging modality for the diagnosis and follow-up of cardiovascular diseases. Comprehensive echocardiographic assessment requires multiple quantitative measurements of cardiac structure and function, which are time-consuming and highly dependent on operator expertise. US2.AI (Us2.v1) is an artificial intelligence (deep learning)-based software designed to automatically analyze standard two-dimensional and Doppler echocardiographic DICOM video clips acquired from different ultrasound vendors. The software provides automated measurements of cardiac morphology and function, including chamber dimensions and volumes, left and right ventricular systolic and diastolic function, myocardial strain, and Doppler-derived parameters, generating a comprehensive echocardiographic report based on current international guideline recommendations. In addition, the software may assist in identifying echocardiographic features suggestive of several cardiovascular conditions, including heart failure, pulmonary hypertension, hypertrophic cardiomyopathy, cardiac amyloidosis, valvular heart disease, and ischemic cardiomyopathy.

Assessment of Cardiac and Carotid Ultrasound Measurements in a Cohort of Healthy Children in Italy

This observational ambispective cohort study aims to establish reference values for cardiac structure and function, coronary artery dimensions, and carotid intima-media thickness (cIMT) in a healthy pediatric population living in Italy. Healthy children aged 0-18 years undergoing cardiologic evaluation will be enrolled. Echocardiographic and carotid ultrasound parameters will be collected together with anthropometric and demographic data. The study includes both retrospective and prospective cohorts.

Short- and Medium-term Results of New Generation Aortic

Over the past decade, aortic valve replacement surgery has undergone significant changes in terms of both the approaches and the prostheses used. In parallel with the historical biological prostheses for aortic valve surgery, a new generation of bioprostheses has been marketed since 2008, with the entry of these new prostheses in the armatorium of the Amiens-Picardy University Hospital since 2010. These are rapid deployment prostheses or prostheses without sutures. As a result, patients undergoing aortic valve replacement have been able to benefit from this type of bioprosthesis during their procedures. There are few publications reporting the 5-year follow-up of these bioprostheses. The investigators therefore decided to follow up patients operated on by a new generation bioprosthesis to study the 5-year survival and the functioning of their bioprostheses, in order to make a scientific contribution to the follow-up of these valves. These patients will be compared to patients who have benefited from the implantation of traditional bioprostheses.

Effects of Magnesium and Spinning Training on Echocardiographic, Inflammatory, and Aerobic Outcomes

Regular aerobic exercise may improve cardiorespiratory fitness while modulating systemic inflammation and oxidative stress. Spinning, as a structured indoor cycling modality, provides a practical aerobic exercise model with adjustable intensity and duration, but its effects on redox balance, inflammatory status, aerobic capacity, and cardiac functional parameters may vary according to individual recovery and nutritional status. Magnesium is an essential micronutrient involved in energy metabolism, muscle contraction-relaxation, ion regulation, and inflammatory and oxidative pathways; therefore, magnesium use may be relevant to exercise adaptation and recovery. This study aims to evaluate the associations of magnesium use and spinning training with oxidative stress, inflammation, aerobic capacity, and cardiac parameters. In this context, biochemical markers related to oxidative/antioxidant status and inflammation, aerobic performance indicators, and echocardiographic cardiac function parameters will be assessed together. The study is expected to provide real-world evidence on whether magnesium use in individuals participating in spinning training is associated with more favorable redox, inflammatory, aerobic, and cardiac profiles.

Cardiac Output Assessment by Using Saline Contrast Injection

Cardiac output (CO) assessment is one of the cornerstone of hemodynamic evaluation in ICU patients. CO is usually measured using invasive methods or non-invasive methods. Thermodilution is considered as the gold standard for CO assessment. Cardiac Doppler as well demonstrated to be accurate but needs manipulations and good knowledge and skills. The investigators developed a new technique using injection of agitated saline solution to evaluate CO without any manual measurement and then observer independent.

Cardiovascular Risk in Peripheral Artery Disease Patients Undergoing Endovascular Revascularisation

This study will investigate heart-related complications in patients with peripheral arterial disease (PAD) undergoing endovascular revascularization procedures to improve blood flow in the legs. Previous studies have shown that some patients develop silent heart injury after these procedures, even without symptoms, and that this may be associated with worse long-term outcomes. Approximately 500 patients will be included in the study. Blood tests for cardiac biomarkers, including high-sensitivity troponin and NT-proBNP, will be performed before and after the procedure. Participants will also undergo ultrasound examination of the heart to assess heart function, including advanced measures that may detect early or subtle heart damage. In addition, heart rate variability will be measured using a short electrocardiogram recording. Patients will be followed for 30 days and 1 year after the procedure to assess the occurrence of major cardiovascular events, limb-related complications, and death. Additional blood samples will be collected and stored for future analysis of inflammation, oxidative stress, and genetic markers that may help explain the mechanisms associated with heart injury and prognosis in these patients.

Cardiac Amyloidosis in HFpEF Tunisian Patients

Cardiac amyloidosis (CA) has recently been reported as a common cause of heart failure with preserved left ventricular ejection fraction (HFpEF), with a prevalence of 6% in elderly HFpEF patients. However, the diagnosis of CA is still challenging and requires multiple costly investigations. Regardless of the type of CA, TTR or AL, early diagnosis significantly improves prognosis. In this study, the investigators aimed to determine the prevalence of CA in Tunisian HFpEF patients and to identify clinical and ultrasound criteria predictive of CA.

Use of Liraglutide in Children Aged 6 to 12 Years With Severe Obesity

This randomized controlled trial evaluates the efficacy, safety, metabolic, and cardiovascular effects of liraglutide in children aged 6 to 12 years with severe obesity. Participants are randomized to receive liraglutide plus lifestyle intervention or lifestyle intervention alone for 6 months. In addition to primary outcomes related to weight loss and metabolic improvement, a predefined subgroup analysis evaluates cardiovascular function in participants receiving liraglutide using advanced echocardiographic techniques, including speckle-tracking-derived myocardial deformation parameters.

DigitHeart Echo Study

Eligible patients will be interviewed by research staff to explain the trial design and rationale. Written informed consent will be obtained from patients who voluntarily agree to participate. Demographics and medical history will be obtained. A 12-lead ECG will be performed; it has not been performed within 6 months. A photo of the 12-lead ECG will be taken by research staff using the DigitHeart-2 smartphone application. Predictions from DigitHeart-2/MERL-ECHO and other machine learning models hosted by the investigator team for each of the target anatomical and mechanical properties will be recorded. The cardiologist in charge of the patient, who is blinded to the prediction results from DigitHeart-2/MERL-ECHO, will perform echocardiography according to American Society of Echocardiography guidelines, which will serve as the gold standard for accuracy evaluation.

Clinical Echocardiography and S' Wave for Early Recognition of Acute Coronary Syndrome in the Emergency Department, A Prospective Study

The goal of this prospective observational study is to assess the diagnostic accuracy of the tissue Doppler imaging (TDI) S' wave in detecting acute coronary syndrome (ACS) in adult patients presenting to the emergency department (ED) with acute chest pain. This study focuses on patients aged 18 years or older, who require continuous cardiac monitoring but do not show ST-elevation myocardial infarction (STEMI) on their initial ECG. The main questions it aims to answer are: * Can TDI S' wave velocity serve as an early diagnostic marker for ACS in the emergency department? * How does the diagnostic performance of TDI S' compare with other echocardiographic markers (MAPSE, TAPSE, and diastolic parameters such as E, E', A, E/A, E/E')? * Do demographic factors (age, sex, BMI, echogenicity) influence the diagnostic accuracy of echocardiographic parameters for ACS? If there is a comparison group: Researchers will compare TDI S' wave velocity findings with the final adjudicated diagnosis of ACS (determined after 3 months) to evaluate its sensitivity and specificity.

Live Stream of Prehospital Emergency Ultrasound in Patients With Acute Dyspnoea

Background: Acute dyspnoea is a common symptom in prehospital emergency medicine. As ultrasound gained in importance for diagnosis in patients with acute respiratory distress, it plays even a role in the prehospital setting. However, prehospital emergency ultrasound (PEU) remains challenging and requires knowledge and skills. New prehospital ultrasound devices offer the possibility for tele-supervision. The impact of tele-supervision of PEU in patients with acute dyspnoea is unclear. Objective: This prospective observational study aims to evaluate the effect of PEU with tele-supervision on diagnosis, treatment strategies and cognitive load in comparison to PEU without tele-supervision in patients with acute dyspnoea. Methods: In total 350 prehospital emergency patients with acute dyspnoea will be included in this study. Patients will be observed in two groups. In group 1 PEU will be performed with tele-supervision, whereas in group 2 PEU will be performed without tele-supervision (tele-supervision not available).

COronoary Microcirculation Analysis NETwork

COMA.NET (Coronary Microcirculation Analysis Network) is a prospective, randomized, open-label, parallel-group clinical trial designed to determine whether endotype-guided pharmacotherapy is superior to standard care in improving quality of life in patients with ischemia with non-obstructive coronary arteries. Approximately 180-190 participants with objective ischemia will be randomized to either the control or the intervention group. Pharmacotherapy based on the endotype established during intracoronary assessment will be introduced in the intervention arm of the study. The primary endpoint is the change in the Seattle Angina Questionnaire (SAQ) score from baseline to 3 months. Secondary endpoints include the diagnostic accuracy of transthoracic echocardiographic coronary flow velocity reserve (CFVR), the incidence of adverse events, associations between biomarkers and coronary microvascular dysfunction (CMD), and the identification of risk factors for specific CMD endotypes. Participants will undergo invasive functional evaluation of the coronary microcirculation, measurement of echocardiographic CFVR, and analysis of selected circulating biomarkers. The study cohort will be followed up at three and six months and will include reassessment of quality of life (Seattle Angina Questionnaire, EuroQol 5-Dimensions 5-Level questionnaire, 12-item Short Form Health Survey), anxiety (Generalized Anxiety Disorder-7 score), and functional status (6-minute walk test). The study began in October 2025. Primary completion is anticipated in October 2027, and the overall study completion date is expected in March 2028.

GLS in Difficult CPB Weaning

The goal of this observational study is to learn whether global longitudinal strain (GLS), measured by echocardiography, can predict difficulty separating from cardiopulmonary bypass (CPB) in adults undergoing elective cardiac surgery. The main questions it aims to answer are: * Can preoperative GLS measurement predict difficult separation from CPB? * Are GLS values associated with outcomes such as intensive care unit (ICU) stay, hospital stay, cardiac biomarkers, or 30-day mortality? Participants will: * Undergo standard cardiac surgery requiring CPB * Have echocardiographic assessments (TTE before and after surgery) * Have their recovery and outcomes monitored, including ICU and hospital stay, postoperative labs, and survival within 30 days

Value of Speckle Tracking Echocardiography Inflammatory Bowel Disease Patients

Value of speckle tracking echocardiography in early assessment of cardiac function in inflammatory bowel disease .