跳至主要内容
临床试验/CTRI/2025/10/095701
CTRI/2025/10/095701尚未招募不适用

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

Ai Health Highway India Private Limited2 个研究点 分布在 1 个国家目标入组 1,400 人开始时间: 2026年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,400
试验地点
2
主要终点
Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •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).

排除标准

  • •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.

结局指标

主要结局

Sensitivity and specificity of AiSteth in detecting cardiac murmurs and heart sounds as compared with comprehensive assessment by a physician, along with echocardiography.

时间窗: 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.

次要结局

  • 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):)

研究者

发起方
Ai Health Highway India Private Limited
申办方类型
Other [Medical Device Start Up ]
责任方
Principal Investigator
主要研究者

Prof Dr Melvin George

SRM Medical College Hospital & Research Centre,

研究点 (2)

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