Cardiac Disease
Conditions
Keywords
Cardiac disease, Novices, Guidance, Artificial intelligence, Ejection Fraction, Ultrasound
Brief summary
The study's objective is to evaluate if exams, performed with the HeartFocus software by novices, are of sufficient quality to visually analyze the left ventricular size, the left ventricular function, the right ventricular size, and the presence of non-trivial pericardial effusion. Novices will be nurses without prior ultrasound experience who have received dedicated training on cardiac ultrasound and on Heartfocus software. Ultrasound exams will be limited to the acquisition of 10 reference views
Detailed description
This prospective multicentric international pivotal trial will evaluate the ability of the Heartfocus software to support novices for the acquisition of 10 reference views of cardiac ultrasound. The 10 reference views are the following: Parasternal long axis, Parasternal short axis at the aortic valve, Parasternal short axis at the mitral valve Parasternal short axis at the papillary muscles Apical 5-chamber, Apical 4-chamber, Apical 3-chamber, Apical 2-chamber, Subcostal 4-chamber, Subcostal inferior vena cava. Patients included in the study will be adult patients scheduled for an echocardiogram at one of the two investigating centers. Ultrasound exams will be limited to the acquisition 10 reference views. Patients will receive 2 additional limited exams, which consist of the acquisition of ultrasound clips for each of the 10 references views: one by a novice, nurses having received a dedicated training of 2 days, with an ultrasound probe and the HeartFocus software with the guidance system, one by an expert (experienced sonographer/cardiologist) with the same ultrasound probe and the HeartFocus software without the guidance system. A total of 8 novices will perform the acquisition on 30 patients each. In total 240 patients will be included in the study, half in each investigator center. The exams (240 acquired by novices, 240 by experts) will be analyzed by cardiologists to assess their quality. The endpoints are described below.
Interventions
DEVICEUsing HeartFocus software with AI guidance (Novices)
The novice are nurses without prior ultrasound experience performed limited echocardiograms using the HeartFocus AI-based guidance software (DESKi). After a half-day training and practice on ≤9 patients, each novice acquired echocardiographic clips for 10 standard transthoracic views with the assistance of real-time software guidance and automated recording.
DEVICEUsing HeartFocus software without AI-guidance
Experienced sonographers and cardiologists performed limited echocardiograms using HeartFocus software, without AI assistance. The experts acquired echocardiographic sequences corresponding to the 10 standard transthoracic views, just like the novices.
Sponsors
DESKi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient (male or female) over 18 years old, Patient having an echocardiography examination scheduled in one of the two investigation centers. Patient who has given his non-objection to participate in the research
Exclusion criteria
Patient subject to a measure of legal protection (safeguard of justice, guardianship or curatorship), Patient deprived of liberty by judicial or administrative decision, Patient being unable to give his non-objection, Pregnant or breastfeeding women, Patient with cardiac anatomy that does not allow reference electrocardiographic sections to be made (situs inversus, single ventricle, congenital anomalies, etc), Patient having benefited from prior echocardiographic exams whose reports mention poor or weak echogenicity, Patient having known chest deformity that has already been mentioned in previous reports or has been the subject of investigations (pectum excavatum), Patient who has undergone total or partial pneumectomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Left Ventricular Size (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the exam had sufficient image quality to allow visual analysis of left ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Left Ventricular Function (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Right Ventricle Size (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as "Yes" (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as "No", the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Presence of Non-trivial Pericardial Effusion (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound exam had sufficient image quality to visually analyze the presence of non-trivial pericardial effusion. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Function of the Right Ventricle (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right ventricular function. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Left Atrium Size (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of left atrium size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Right Atrium Size (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of right atrium size. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Segmental Kinetics of the Left Ventricle (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the segmental kinetics of the left ventricle. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Aortic Valve (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the aortic valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Mitral Valve (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the mitral valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Tricuspid Valve (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the tricuspid valve. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| The Size of Inferior Vena Cava (Qualitative Visual Assessment) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the ultrasound examination had sufficient image quality to allow visual analysis of the size of the inferior vena cava. Each exam was independently reviewed by five cardiologists. If at least three cardiologists rated the exam as 'Yes' (sufficient quality), the exam was classified as having sufficient image quality; if at least three rated it as 'No', the exam was classified as not sufficient. The results represent the percentage of scans evaluated as having sufficient image quality. |
| Apical-2-Chamber (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Apical-2-Chamber (A2C) clip had sufficient image quality for interpretation, in order to determine the entire endocardial contour of the left ventricle, calculate ejection fraction by Simpson's method, and detect wall motion abnormalities. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Apical-3-Chamber (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Apical-3-Chamber (A3C) clip had sufficient image quality for interpretation, in order to determine the endocardial definition of the left ventricle, detect wall motion abnormalities, and ensure that the right ventricle and aortic valve leaflets were correctly visualized. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Apical-4-Chamber (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Apical-4-Chamber (A4C) clip had sufficient image quality for interpretation, in order to determine the entire endocardial contour of the left ventricle, calculate ejection fraction by Simpson's method, and detect wall motion abnormalities. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Apical-5-Chamber (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | "For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Apical-5-Chamber (A5C) clip had sufficient image quality for interpretation, in order to determine the endocardial definition of the left ventricle and ensure proper visualization of the outflow chamber and aortic valve. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Parasternal Long Axis (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Parasternal Long-Axis (PLAX) clip had sufficient image quality for interpretation, in order to ensure that the basal segments of the left ventricle were visible with adequate image quality for diameter measurement and detection of wall motion abnormalities, and to confirm that the long axis, aortic valve, and right ventricle were correctly visualized to consider the view as a good PLAX. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Parasternal Short Axis Aortic (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Parasternal Short-Axis Aortic (PSAX-AV) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to visualize the aortic valve leaflets. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Parasternal Short Axis Mitral (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Parasternal Short-Axis Mitral (PSAX-MV) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to detect wall motion abnormalities and visualize valvular movement. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Parasternal Short Axis Papillary Muscles (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Parasternal Short-Axis Papillary Muscles (PSAX-PM) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to detect wall motion abnormalities, visualize valvular movement, and visualize both papillary muscles. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Sub Costal-4-Chamber (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Subcostal 4-Chamber (SC-4C) clip had sufficient image quality for interpretation, in order to ensure adequate image quality for detecting a pericardial effusion between the right ventricle and liver. Full visualization of the left and right ventricles was not required. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
| Sub Costal Inferior Vena Cava (Diagnostic Quality Clip) | Images evaluated by the cardiologists after the acquisition | For each participant, one novice and one expert performed a limited echocardiographic exam on the same patient, so that the quality of each exam could be evaluated by cardiologists. Blinded cardiologists evaluated whether the Subcostal Inferior Vena Cava (SC-IVC) clip had sufficient image quality for interpretation, in order to ensure adequate image quality to measure the diameter of the IVC a few centimeters before it reaches the heart. Each clip was independently reviewed by five cardiologists. If at least three cardiologists rated the clip as 'Yes' (sufficient quality), the clip was classified as a Diagnostic Quality Clip (DQC); if at least three rated it as 'No', the clip was classified as not sufficient. The results represent the percentage of Diagnostic Quality Clips (DQC) obtained. |
Countries
France, United States
Contacts
PRINCIPAL_INVESTIGATORBiana Trost, MD, FACC, FASE
Department of Cardiology Lenox Hill Hospital
Participant flow
Recruitment details
Adult patients (≥18 years) scheduled for a clinically indicated echocardiogram were consecutively recruited at two academic medical centers: University Hospital of Bordeaux (France) and Lenox Hill Hospital (New York, USA). Recruitment occurred between november 2023 and august 2024.
Pre-assignment details
A total of 247 patients were screened. Of these, 246 provided informed consent; among these, 6 participants withdrew before undergoing the study echocardiography. Reasons included withdrawal of consent (n=3), scheduling conflicts (n=2), and technical difficulties (n=1). Thus, 240 patients were finally enrolled in this study, meaning that they completed both novice and expert echocardiography exams and were included in the Full Analysis Set.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized | 62.6 Years |
| BMI (Body Mass Index) <25 | 41 Participants |
| BMI (Body Mass Index) ≤25-30 | 93 Participants |
| BMI (Body Mass Index) ≥30 | 50 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 132 Participants |
| Prior cardiac diagnoses Atrial fibrillation | 8.3 Percentage of participants (%) |
| Prior cardiac diagnoses Cardiomyopathies | 10.4 Percentage of participants (%) |
| Prior cardiac diagnoses Congenital heart disease | 0.0 Percentage of participants (%) |
| Prior cardiac diagnoses Coronary artery disease | 15.8 Percentage of participants (%) |
| Prior cardiac diagnoses Diabetes | 19.2 Percentage of participants (%) |
| Prior cardiac diagnoses Heart failure | 9.2 Percentage of participants (%) |
| Prior cardiac diagnoses Heart transplant | 3.3 Percentage of participants (%) |
| Prior cardiac diagnoses Hyperlipidemia | 58.3 Percentage of participants (%) |
| Prior cardiac diagnoses Hypertension | 41.7 Percentage of participants (%) |
| Prior cardiac diagnoses None | 17.5 Percentage of participants (%) |
| Prior cardiac diagnoses Not reported | 0.8 Percentage of participants (%) |
| Prior cardiac diagnoses Other | 7.1 Percentage of participants (%) |
| Prior cardiac diagnoses Other arrhythmias | 7.5 Percentage of participants (%) |
| Prior cardiac diagnoses Prior heart attack | 0.0 Percentage of participants (%) |
| Prior cardiac diagnoses Pulmonary hypertension | 2.9 Percentage of participants (%) |
| Prior cardiac diagnoses Valvular heart disease | 25.8 Percentage of participants (%) |
| Prior noncardiac diagnoses Cancer | 21.7 Percentage of participants (%) |
| Prior noncardiac diagnoses COPD/emphysema | 4.2 Percentage of participants (%) |
| Prior noncardiac diagnoses None | 42.5 Percentage of participants (%) |
| Prior noncardiac diagnoses Not reported | 0.8 Percentage of participants (%) |
| Prior noncardiac diagnoses Other | 30.4 Percentage of participants (%) |
| Prior noncardiac diagnoses Pulmonary embolus | 1.7 Percentage of participants (%) |
| Prior noncardiac diagnoses Renal disease | 10.0 Percentage of participants (%) |
| Prior noncardiac diagnoses Systemic infiltrative disease | 0.8 Percentage of participants (%) |
| Prior noncardiac diagnoses Underwent chemotherapy | 10.0 Percentage of participants (%) |
| Prior noncardiac diagnoses Underwent radiation | 2.5 Percentage of participants (%) |
| Race American Indian/Alaska Native | 0 Participants |
| Race Asian | 3 Participants |
| Race Black/African American | 36 Participants |
| Race Other | 0 Participants |
| Race Unknown/not reported | 131 Participants |
| Race White | 52 Participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 240 |
| other Total, other adverse events | 0 / 240 |
| serious Total, serious adverse events | 0 / 240 |
Outcome results
None listed