Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
IMPROVE
2 other identifiers
interventional
1,440
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2026
CompletedFirst Submitted
Initial submission to the registry
August 4, 2026
CompletedFirst Posted
Study publicly available on registry
August 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
August 10, 2026
August 1, 2026
1.8 years
August 4, 2026
August 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
New diagnosis of ≥ moderate aortic or mitral valvular heart disease or left ventricular systolic dysfunction (ejection fraction ≤50%), confirmed by standard transthoracic echocardiography performed within 90 days of the index clinic visit. Assessed using the disease detection rate (true positives/total number of patients in the study).
90 days from index clinic visit
Secondary Outcomes (3)
Recall Rate
90 days from index clinic visit
Referrals to cardiology or cardiac surgery
2 years from index clinic visit
Major adverse cardiac events (MACE)
2 years from index clinic visit
Other Outcomes (3)
Downstream Processes of Care
90 days from index clinic visit
AI-POCUS Adoption
6 months post-implementation
Acceptability and Feasibility of AI-POCUS
Through study completion, estimated 2 years
Study Arms (2)
AI-POCUS Screening
EXPERIMENTALTrained clinic staff perform AI-guided point-of-care ultrasound using the Kosmos Torso-One device on eligible patients during routine primary care or geriatrics visits. Patients with ≥ moderate valvular heart disease or EF ≤50% are referred for confirmatory echocardiography within 90 days.
Usual Care
NO INTERVENTIONEligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.
Interventions
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.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Samuel & Jean Frankel Cardiovascular Center
Ann Arbor, Michigan, 48109, United States
Parkland Health
Dallas, Texas, 75390, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The echocardiographic core laboratory analysts are blinded to participant arm assignment (AI-POCUS vs. usual care) when interpreting all transthoracic echocardiograms and POCUS images.
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
August 4, 2026
First Posted
August 10, 2026
Study Start
August 1, 2026
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
August 10, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will not be shared at this time. The study involves vulnerable older adult populations across two clinical sites, and data sharing requires additional privacy and governance review. Data sharing may be considered upon study completion pending IRB approval and execution of appropriate data use agreements.