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

Starting soon · Not applicable

Conditions studied: Valvular Heart Disease Patients, Aortic Stenosis, Mitral Regurgitation, Left Ventricular Diastolic Dysfunction

In brief

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.

Key facts

Study ID: NCT07756398
Run by: University of Texas Southwestern Medical Center
People needed: 1440
Starts: 2026-08-01
Expected to finish: 2028-12-01
Last updated by the study team: 2026-08-10

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 65-85 years Presenting for a new or established visit at a primary care or geriatrics clinic at UT Southwestern Medical Center or Parkland Hospital Seen by a provider cluster enrolled in the study No prior known aortic or mitral valvular heart disease No prior known left ventricular systolic dysfunction (EF ≤50%) No prior echocardiography demonstrating structural heart disease

You may not qualify if…

Age younger than 65 or older than 85 years Prior known diagnosis of aortic or mitral valvular heart disease Prior known left ventricular systolic dysfunction Prior echocardiography showing structural heart disease Unable or unwilling to provide informed consent

Where it is running

Samuel & Jean Frankel Cardiovascular Center — Ann Arbor, Michigan, United States
Parkland Health — Dallas, Texas, United States
University of Texas Southwestern Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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