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

2026年8月12日 更新者：Dharam Kumbhani、University of Texas Southwestern Medical Center

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Structural heart disease (SHD) - principally degenerative valvular heart disease (VHD) and left ventricular systolic dysfunction (LVSD) - affects an estimated 21.7% of adults aged 65 and older and carries substantial morbidity and mortality, yet detection relies on passive case finding through auscultation and subsequent echocardiography referral. AI-guided point-of-care ultrasound (AI-POCUS) offers a means of systematic screening at the point of routine ambulatory care by operators without formal sonography training.

IMPROVE is a hybrid type 1 effectiveness-implementation, stratified, cluster-randomized trial. The unit of randomization is the provider cluster: each participating primary care or geriatrics physician or advanced practice provider, 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 (UT Southwestern Medical Center and Parkland Health & Hospital System), with approximately 1,088 patients aged 65-85 enrolled over 24 months.

In intervention clusters, trained clinic staff perform protocolized AI-guided POCUS using the Kosmos Torso-One device, together with a 2 mL NT-proBNP blood draw. Images are reviewed by a blinded echocardiographic core laboratory; participants with at least moderate VHD or LVEF 50% or less are referred for confirmatory transthoracic echocardiography, with all subsequent management at the treating provider's discretion. Usual care clusters receive standard care and are monitored for echocardiography referral within 90 days of the index visit. All echocardiograms performed within 90 days in either arm are interpreted in the core lab in a blinded fashion.

The primary outcome (Aim 1) is a new diagnosis of at least moderate VHD or LVSD confirmed by complete echocardiography within 90 days of screening. Secondary outcomes include downstream care processes and major adverse cardiovascular events over 2 years. Aim 2 evaluates implementation determinants and outcomes - adoption, acceptability, appropriateness, and feasibility - using CFIR and Proctor's taxonomy, through structured workflow observations and semi-structured interviews. The primary analysis is intention-to-treat using a generalized linear mixed model with provider-level random effects.

研究类型

介入性

注册 (估计的)

1088

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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
  • Agrees to participate, to undergo randomization, and to permit inclusion of all eligible patients from the panel
  • 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

Exclusion Criteria:

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

    1 year or less

  • Unable to provide informed consent

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：放映
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：AI-POCUS Screening
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.
设备：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.
无干预：Usual Care
Eligible patients receive standard provider-driven care. Echocardiography referral occurs per routine clinical indications such as auscultated murmur or patient-reported symptoms.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
New diagnosis of structural heart disease (≥ moderate valvular heart disease or left ventricular systolic dysfunction)
大体时间：90 days from index clinic visit
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

次要结果测量

结果测量
措施说明
大体时间
Recall Rate
大体时间：90 days from index clinic visit
Proportion of AI-POCUS screening studies requiring further workup, defined as total number of positive screens (true + false positives) divided by total number of patients in the study.
90 days from index clinic visit
Referrals to cardiology or cardiac surgery
大体时间：2 years from index clinic visit
Proportion of participants with a new referral to cardiology or cardiac surgery, ascertained through electronic health record review.
2 years from index clinic visit
Major adverse cardiac events (MACE)
大体时间：2 years from index clinic visit
Composite of all-cause mortality, stroke, and cardiovascular hospitalization. Deaths ascertained through EHR review and annual National Death Index query. Stroke and cardiovascular hospitalization ascertained through participant self-report at follow-up, EHR review, and primary discharge diagnoses (ICD-10-CM), with additional confirmation from regional hospital claims data.
2 years from index clinic visit

其他结果措施

结果测量
措施说明
大体时间
Downstream Processes of Care
大体时间：90 days from index clinic visit
Composite of additional cardiac testing (transthoracic or transesophageal echocardiography, cardiac catheterization, cardiac CT, cardiac MRI), medication initiation, and valve procedures (surgical or transcatheter aortic or mitral valve repair or replacement), ascertained via EHR review using CPT codes.
90 days from index clinic visit
AI-POCUS Adoption
大体时间：6 months post-implementation
Rate of AI-POCUS use among providers randomized to the intervention arm, assessed through structured clinic observations at baseline, 3 months, and 6 months post-implementation.
6 months post-implementation
Acceptability and Feasibility of AI-POCUS
大体时间：Through study completion, estimated 2 years
Assessed through semi-structured interviews with providers, clinic staff, and patients in the intervention arm, guided by the Consolidated Framework for Implementation Research (CFIR) and Proctor's taxonomy of implementation outcomes.
Through study completion, estimated 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Texas Southwestern Medical Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月1日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年8月4日

首先提交符合 QC 标准的

2026年8月4日

首次发布 (实际的)

2026年8月10日

研究记录更新

最后更新发布 (实际的)

2026年8月17日

上次提交的符合 QC 标准的更新

2026年8月12日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • STU20260660
  • 95057 (其他标识符：University of Texas Southwestern Medical Center)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

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.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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