Validation of a triage tool (AI enabled Smart Stethoscope ) for screening heart sounds and murmurs using AiSteth Murmur Analysis Platform (AsMAP)- A cross-sectional study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 1,400
- Locations
- 2
- Primary Endpoint
- Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.
Study Overview
Brief Summary
Valvular Heart Disease (VHD) is a leading cause of cardiovascular morbidity and mortality worldwide and the resultant disease burden is only projected to increase in the coming decades. The prevalence of rheumatic heart disease, the most common form of valvular heart disease affects approximately 41 million individuals, has been on the rise in developing countries. This trend is likely linked to the growth of the young adult demographic and a reduction in premature mortality, attributed to enhanced access to antibiotics, microbiological diagnostics, and echocardiography. In developed nations, aortic valve stenosis is the most frequently encountered valvular condition, impacting around 9 million people globally, with its prevalence increasing due to an aging population and a higher incidence of atherosclerosis. Aortic regurgitation, which is linked to diastolic hypertension but not systolic hypertension, has similarly seen an uptick in prevalence in developed regions. Mitral regurgitation affects 24 million individuals worldwide, with significant variability across different countries. Primary mitral regurgitation typically results from myxomatous degeneration and mitral valve prolapse, largely influenced by genetic factors, while secondary mitral regurgitation constitutes 65% of cases and arises from dilation and heart failure. Additionally, tricuspid regurgitation has become more common in developed nations, largely due to the increased use of intracardiac pacemakers. Cardiovascular diseases (CVDs) and pathological murmurs are intricately linked, as murmurs often serve as clinical indicators of underlying cardiac abnormalities that can contribute to or signify various cardiovascular conditions. Pathological murmurs result from turbulent blood flow within the heart, which can be caused by structural defects such as valve abnormalities (e.g., stenosis or regurgitation), congenital heart defects, or other cardiac pathologies. These murmurs may be benign or indicative of serious conditions like hypertrophic cardiomyopathy, aortic aneurysms, or infective endocarditis, all of which are associated with increased risk of cardiovascular morbidity and mortality.
The examination of the cardiovascular system and the practice of cardiac auscultation serve as valuable tools in identifying murmurs. Furthermore, cardiac auscultation has proven to be beneficial in identifying valvular diseases in patients who exhibit no symptoms. Utilizing AIenabled stethoscopes presents an innovative approach to enhancing the efficiency and accuracy of pathological murmur detection. In addition, the rural regions of our nation lack sophisticated diagnostic capabilities for detecting cardiovascular diseases. Therefore, employing AI-enabled stethoscopes allows us to conduct screenings for pathological murmurs even by untrained health workers. Additionally, we can facilitate teleconsultations and arrange referrals for necessary follow-ups., enabling timely intervention to mitigate associated risks and improve patient outcomes.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 1.00 Month(s) to 80.00 Year(s) (—)
- Sex
- All
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
- •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
- •Individuals with poor acoustic windows due to significant obesity, chest wall deformities, or surgical interventions that impair heart sound acquisition
- •Patients with active pulmonary conditions (e.g., pneumonia, bronchospasm, pleural effusion) are likely to produce confounding auscultatory findings
- •Participants with acute cardiovascular emergencies, such as acute myocardial infarction, cardiac tamponade, or unstable arrhythmias, were immediate care overrides study participation
- •Individuals with severe psychiatric illness or cognitive impairment that impairs understanding of consent or compliance with study procedures
- •Pregnant women in the third trimester, due to altered hemodynamics that may affect auscultation and signal interpretation
- •Patients currently undergoing thoracic surgery or intensive care interventions.
Outcomes
Primary Outcomes
Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.
Time Frame: 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 Outcomes
- Sensitivity and specificity of AiSteth Murmur Analysis Platform’s (AsMAP) algorithms for detecting heart sounds and murmurs as compared with a conventional stethoscope.(During the single study visit (about 30 minutes):)
Investigators
Prof Dr Melvin George
SRM Medical College Hospital & Research Centre,
