Device for Noninvasive Detection of Coronary Artery Disease - Revised

DESCRIPTION (provided by applicant): Heart disease is the leading cause of death for both women and men in the industrial world and despite the fact that early detection of CAD allows for successful and cost effective treatment of the disease, only 20% of CAD cases are diagnosed prior to a heart attack. Based on principles pioneered by the PI, SonoMedica, Inc. has developed a device that can non-invasively detect CAD in both its early (30% to 50% occlusive) and later stages (50% to 85% occlusive) by identi fying the acoustic signatures associated with turbulent blood flow through partially occluded coronary arteries. No other approach to the detection of CAD promises to be as inexpensive, simple to perform, and risk free as the acoustic-based approach. The b enefits to society of this device include wellness testing (screening) for asymptomatic individuals as well as longitudinal tracking of symptomatic patients. The objective milestone of Phase I research was to improve acoustic-based detection of CAD so that blockages between 30% to 85% could be detected with a sensitivity of 95% at a specificity of 80%. These goals were met as a single feature parameter was developed that achieves this level of diagnostic performance. The overriding goal of this Phase II pro posal is to develop a marketable product to be placed in clinical trials in a number of hospitals. To achieve this goal, several tasks are proposed that will: further improve device performance through algorithm refinement, enhance the ability of the devic e to tolerate ambient noise by adding adaptive noise cancellation; and improve ease of use by adding online evaluations of data quality and artifact detection. The upgraded devices will then be evaluated in a prospective clinical study. This work also incl udes plans to develop a Phase II clinical trial and related marketing and commercialization efforts. RELEVANCE: The medical instrument that will be developed in this proposal addresses a major medical issue, the noninvasive detection of blockages in th e coronary arteries. This disease, know as coronary artery disease, is arguably the most important fatal disease in the US, causing one-third to one-half of all deaths in people between the ages of 35 and 64. The instrument being developed is based on acou stic detection of turbulent blood flow and promises to be less expensive and easier to use than any other approach, and it is completely risk free. The substantial benefits to society of this device include wellness testing (screening) for asymptomatic ind ividuals and longitudinal tracking of symptomatic patients.