AI-Guided Ultrasound for Heart Disease

(IMPROVE Trial)

This trial aims to determine if an AI-guided handheld ultrasound, specifically the Kosmos Torso-One AI-guided Point-of-Care Ultrasound, can detect heart problems earlier than usual methods during routine doctor visits. It focuses on identifying heart valve disease and a weak heart muscle, which are often difficult to detect before causing serious issues. Patients visiting doctors using this AI tool may receive a quick ultrasound and a blood test. If the ultrasound indicates a problem, they will undergo a detailed heart exam. This trial is suitable for adults aged 65 to 85 who are visiting a participating clinic and have not had a heart ultrasound in the past five years. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could improve early detection of heart issues.

In a previous study, researchers used the Kosmos Torso-One AI-guided ultrasound device to scan over 1,200 patients. The results showed that individuals without specialized training could use the device effectively and safely. It correctly identified heart issues 89 to 94 percent of the time, demonstrating high reliability. Additionally, the FDA has approved the Kosmos platform, indicating that it meets strict safety standards for medical devices. This approval confirms the device's safety and tolerability for use on people.¹²³⁴⁵

Researchers are excited about AI-guided ultrasound for heart disease because it offers a new, potentially more efficient way to detect heart issues early. Unlike traditional methods that rely on manual echocardiography referrals based on symptoms or physical findings, the Kosmos Torso-One device uses artificial intelligence to guide clinic staff in performing point-of-care ultrasounds. This approach could lead to earlier detection of conditions like moderate valvular heart disease or reduced ejection fraction, allowing for quicker intervention. By integrating AI into routine check-ups, this method promises to streamline the diagnostic process and expand access to advanced care without needing specialized sonographers.

Research has shown that AI-guided ultrasounds effectively detect heart problems. In 95% of cases, the Kosmos Torso-One device provided quick answers to important heart health questions. Studies have found that when non-experts used this AI-powered device, it achieved accuracy rates of 89% to 94%. This tool excels at identifying issues such as heart pumping efficiency and valve problems. In this trial, participants in the AI-POCUS Screening arm will receive AI-guided point-of-care ultrasound using the Kosmos Torso-One device. These findings suggest that AI-guided ultrasound might help detect heart disease earlier than usual methods, potentially preventing serious complications.¹²⁶⁷⁸