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

NCT07756398 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: STU2026066095057
• Study Type: interventional
• Target: 1,088
• Locations: 1 country
• Sites: 2

Brief Summary

Heart valve disease and weakened heart muscle (left ventricular systolic dysfunction) are common in older adults and often go undetected until serious complications such as heart failure develop. Detection currently depends on a clinician hearing a murmur and then ordering an echocardiogram, which is easily missed or delayed. This study tests whether a brief, artificial intelligence (AI)-guided handheld heart ultrasound - point-of-care ultrasound, or POCUS - performed by trained clinic staff during a routine visit identifies these conditions earlier than usual care. Primary care and geriatrics providers, rather than individual patients, are assigned by chance to one of two groups. Patients seen by providers in the AI-ultrasound group are offered a POCUS scan and a one-time blood test at their regular visit, and are referred for a confirmatory echocardiogram if the scan is abnormal. Patients seen by providers in the usual care group receive standard clinic care. Researchers will compare how often previously undiagnosed structural heart disease is newly identified in each group.

Conditions

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

Keywords

Point-of-care ultrasound; POCUS; Artificial Intelligence; AI-guided imaging; Echocardiography; Screening; Early detection; Heart Failure; Older Adults; Geriatrics; Primary Care; Cluster randomized Trial; Implementation Science

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

EXPERIMENTAL

Trained 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.

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

Usual Care

NO INTERVENTION

Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.

Interventions

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

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.

AI-POCUS Screening

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Provider (cluster) participants:
• Physician or advanced practice provider (physician assistant or nurse practitioner) practicing in primary care or geriatrics at a participating institution who independently assesses patients
• Patient panel comprising \>50% adults aged 65 years or older
• Sees patients in ambulatory clinic at least 1 day per week on average
• Provides written informed consent
• Patient participants:
• Adults aged 65 to 85 years, inclusive
• Attending a scheduled outpatient visit at a participating geriatrics or primary care clinic
• Willing and able to provide written informed consent and, if the AI-POCUS screen is positive, to return for a confirmatory echocardiogram

You may not qualify if:

• Provider (cluster) participants:
• Serving in a locum tenens or other temporary capacity
• Unwilling or unable to nominate an AI-POCUS champion from the clinic
• Patient participants:
• Echocardiogram performed within the past 5 years
• At least moderate aortic or mitral valve disease, or left ventricular ejection fraction 50% or less, documented on any prior echocardiogram
• History of surgical or transcatheter intervention for aortic or mitral valve disease
• Self-reported structural heart disease
• Significant frailty burden or comorbidities limiting life expectancy to
• year or less
• Unable to provide informed consent

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

Parkland Health

Dallas, Texas, 75390, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Mitral Valve Insufficiency; Ventricular Dysfunction, Left; Heart Failure

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Ventricular Dysfunction

Central Study Contacts

Dharam J Kumbhani, MD, SM, MRCP, FACC, FAHA, FSCA

CONTACT

214-645-7508; dharam.kumbhani@utsouthwestern.edu

Ritika Dhruve, MBBS, MPH

CONTACT

ritika.dhruve@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, treating providers, and investigators are aware of cluster assignment. All AI-POCUS images and all transthoracic echocardiograms performed within 90 days of the index visit in either arm are interpreted by an independent echocardiographic core laboratory blinded to arm assignment and to participant clinical information.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Stratified cluster-randomized trial. The unit of randomization is the provider cluster: each participating primary care or geriatrics physician or advanced practice provider, together with their patient panel, constitutes one cluster. Thirty-two clusters are randomized 1:1 to AI-POCUS screening or usual care, stratified by hospital system, with 16 clusters per system (8 per arm). All eligible patients seen by a given provider are assigned to that provider's arm.

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 17, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)