None listed
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Sponsors
Ai Health Highway India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants who are able and willing to provide informed consent (or assent with guardian consent in the case of minors) 2.Participants aged above 10 years, including adolescents and adults (pediatric and adult populations), of any gender. The upper age limit is set at 80 years. 3.Individuals with a valid echocardiography report within the last 3 months that includes comprehensive parameters (M-mode, Doppler, and Color Doppler) 4.Individuals willing to undergo echocardiography for the study if a recent report is not available 5.Participants presenting to OPD or IPD with cardiac complaints or referred for cardiac evaluation 6.Individuals with clinically suspected heart murmurs or valvular disease, irrespective of symptom status 7.Individuals with stable hemodynamic status at the time of auscultation (no acute distress or emergency) 8.Participants whose chest anatomy allows for proper auscultation (e.g., no obstructing wounds or dressings)
Exclusion criteria
Exclusion criteria: 1. Presence of implanted cardiac devices (e.g., pacemaker, implantable cardioverter defibrillators (ICDs), and left ventricular assist devices (LVADs) Cardiac Resynchronization Therapy (CRT), as these can interfere with murmur detection and acoustic signals 2. Individuals with poor acoustic windows due to significant obesity, chest wall deformities, or surgical interventions that impair heart sound acquisition 3. Patients with active pulmonary conditions (e.g., pneumonia, bronchospasm, pleural effusion) are likely to produce confounding auscultatory findings 4. Participants with acute cardiovascular emergencies, such as acute myocardial infarction, cardiac tamponade, or unstable arrhythmias, were immediate care overrides study participation 5. Individuals with severe psychiatric illness or cognitive impairment that impairs understanding of consent or compliance with study procedures 6. Pregnant women in the third trimester, due to altered hemodynamics that may affect auscultation and signal interpretation 7. Patients currently undergoing thoracic surgery or intensive care interventions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.Timepoint: There are no repeated follow ups. It is a single visit cross sectional study. During the single study visit (about 30 minutes): - Comprehensive history and physical examination - Auscultation with conventional stethoscope - Auscultation with AiSteth (minimum 30 seconds exposure) - Echocardiography (if not available within last 3 months, then performed at study site) All assessments are done on the same day. There is no follow up after this visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity and specificity of AiSteth Murmur Analysis Platform s (AsMAP) algorithms for detecting heart sounds and murmurs as compared with a conventional stethoscope.Timepoint: During the single study visit (about 30 minutes): - Conventional stethoscope auscultation | — |
Countries
India
Contacts
Public ContactProf Dr Melvin George
SRM Medical College Hospital & Research Centre,
Outcome results
None listed