Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)

Summary

Structural heart disease (SHD), including valvular heart disease and left ventricular systolic dysfunction, is common in older adults and often goes undetected until symptoms or complications such as heart failure develop. Current detection relies on opportunistic clinical evaluation, including cardiac auscultation, which has limited sensitivity and is inconsistently performed, and echocardiography, which is accurate but resource-intensive. The IMPROVE trial (IMportance of Point-of-caRe ultrasOund for Early Detection of Valvular and Cardiac DiseasEs) evaluates whether an artificial intelligence-guided point-of-care ultrasound (POCUS) screening strategy, embedded in routine primary care and geriatrics ambulatory visits, increases detection of clinically significant SHD compared with usual care. Provider clusters at three health systems will be randomized 1:1 to the AI-POCUS screening strategy or usual care, and approximately 1,440 patients aged 65 years and older will be enrolled over 24 months. In the screening arm, trained clinic staff will acquire cardiac images using an AI-guided handheld ultrasound device; images will be analyzed by FDA-cleared AI software under core laboratory supervision, and patients with a positive screen will be referred to their primary care provider for consideration of a confirmatory transthoracic echocardiogram. The primary outcome is a new diagnosis of SHD (moderate or greater valvular disease, or left ventricular ejection fraction of 50% or less) confirmed by echocardiography within 90 days of the index visit. Secondary outcomes include recall rate, downstream testing and costs, cardiology or cardiac surgery referrals, and major adverse cardiac events over two years. The trial uses a type 1 hybrid effectiveness-implementation design and will concurrently assess the acceptability, feasibility, and determinants of AI-POCUS adoption in ambulatory practice.

Conditions

• Valvular Heart Disease Patients
• Aortic Stenosis
• Mitral Regurgitation
• Left Ventricular Diastolic Dysfunction

Interventions

DEVICE

Kosmos Torso-One AI-guided Point-of-Care Ultrasound (EchoNous, Inc.)

A single AI-guided handheld POCUS examination performed by trained clinic staff (medical or certified nursing assistants) during a routine primary care or geriatrics visit. Acquisition is standardized, including parasternal long- and short-axis and apical 3- and 4-chamber views, with 2D imaging, color Doppler, M-mode of the mitral valve, and continuous-wave Doppler of the aortic and mitral valves. Images are transmitted to a central echocardiographic core laboratory, which screens for adequacy; adequate studies are analyzed by pre-specified AI algorithms based on 2017 ASE guidelines, blinded to arm assignment. A positive screen is defined as moderate or greater valvular heart disease or left ventricular ejection fraction of 50% or less. Positive results are communicated to the participant's primary care provider with a recommendation to consider confirmatory TTE; ordering remains at provider discretion, and the study team facilitates completion within 90 days of index visit.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2028-06-01

Completion

2028-12-01

FDA Device

Yes

Countries

• United States

Study Locations