Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease (CACTUS)

September 21, 2026 updated by: Pierre Elias

Doctors are testing a new tool called EchoNext to see if it can help find heart problems earlier. EchoNext looks at the heart's electrical test, called an ECG, and uses artificial intelligence (AI) to check for signs of structural heart disease (SHD). SHD includes conditions like weak heart pumping, heart valve problems, or extra thickening of the heart muscle. These problems are common but often go undiagnosed until they cause serious issues like heart failure or stroke.

The main questions this study will answer are:

Can EchoNext alerts help emergency doctors find hidden heart problems sooner?

Does this lead to more follow-up heart tests, like an echocardiogram (heart ultrasound)?

What this means for patients: If a person has an ECG in the Emergency Department, the EchoNext tool may be used to check their heart. If the tool finds something unusual, their doctor may receive an alert and may then recommend further heart tests or follow-up care.

This study will help researchers learn if using EchoNext improves early diagnosis and treatment of heart disease.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Structural heart disease (SHD) is a major cause of illness and death, especially in older adults. SHD includes conditions such as valvular heart disease (e.g., aortic stenosis, mitral regurgitation), left or right ventricular dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, and pericardial effusions. These conditions are often underdiagnosed, and delayed recognition can lead to complications such as heart failure, stroke, and cardiomyopathy. Early detection and treatment can improve outcomes, but current approaches often miss patients in the early stages of disease.

EchoNext is an artificial intelligence model trained on over 400,000 ECG-echocardiogram pairs. It analyzes the standard 12-lead ECG to predict the presence of structural heart disease, as defined by echocardiographic findings. The model has demonstrated strong diagnostic performance, with an area under the receiver operating characteristic (AUROC) curve of 0.86 across diverse populations.

The purpose of this trial is to evaluate whether deploying EchoNext into the Emergency Department (ED) electronic health record (EHR) as a clinical decision support alert can increase the detection of undiagnosed SHD. The ED setting is ideal because: (1) ECGs are widely obtained for many presenting complaints, (2) abnormal ECG findings related to SHD are often overlooked in the acute setting, and (3) EDs provide access to disadvantaged populations and a unique opportunity to deliver population-level interventions.

In this study, ECGs obtained in the ED will be analyzed in real time by the EchoNext model. If the model predicts moderate or severe SHD, an EHR alert will be displayed to the treating provider (attending physician, fellow, resident, physician assistant, or nurse practitioner). The alert will inform providers of the potential for underlying SHD and recommend consideration of follow-up echocardiography or specialty referral. Outcomes will include rates of new SHD diagnoses confirmed by echocardiography, follow-up testing and referrals, and downstream patient outcomes.

The Community Tele-Paramedicine (CTP) program, an established post-discharge care initiative at NewYork-Presbyterian, will also serve as a follow-up resource for patients identified in the ED. CTP combines home visits by community paramedics, telehealth visits by emergency physicians, and nurse care management to coordinate outpatient testing and follow-up care. Integration with CTP will facilitate timely echocardiography and referral for patients flagged by EchoNext, particularly for high-risk or underserved populations.

This trial will determine whether AI-driven ECG interpretation can improve early detection of SHD and lead to better patient outcomes compared to standard care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Irving Medical Center / NewYork-Presbyterian
        • Contact:
        • Principal Investigator:
          • Pierre Elias, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 40 years of age or older
  • Received an ECG upon presentation to the Emergency Department

Exclusion Criteria:

  • Had an echocardiogram within the prior 2 years.
  • Has a history of structural heart disease.
  • Not able to receive follow-up based on Community Tele-Paramedicine care manager review.
  • Quality of life will not improve over the next five years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standard Treatment - No EHR Alert

Emergency department providers will not be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram.
Experimental: Intervention - EHR Alert & Community Tele-paramedicine

Emergency department providers will be alerted in the electronic health record (EHR) if a patient's electrocardiogram (ECG) ordered in the ED is identified by the EchoNext algorithm as suggesting structural heart disease (SHD) and potentially benefit from an echocardiogram. These patients will also be referred to Community Tele-paramedicine for follow-up for potential echocardiogram.
Device: EHR Alert

EKG Algorithm to identify structural heart disease

Other Names:
  • EchoNext

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of new diagnoses of Structural Heart Disease (SHD)
Time Frame: 180 days post index ED visit

Number of patients with a new diagnosis of structural heart disease (SHD), including moderate or greater valvular disease, left or right ventricular systolic dysfunction, left ventricular hypertrophy, pulmonary artery hypertension, or moderate/large pericardial effusions, confirmed by echocardiography or other clinical evaluation.
180 days post index ED visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of echocardiography ordering
Time Frame: 180 days post index ED visit

Proportion of patients who received an echocardiogram following the index ED visit.
180 days post index ED visit
New Medical Treatments for SHD
Time Frame: 180 days post index ED visit

Number of patients initiating new cardiovascular medications (e.g., antihypertensives, diuretics) specifically for treatment of structural heart disease.
180 days post index ED visit
New Surgical or Procedural Interventions for SHD
Time Frame: 180 days post-index ED visit

Number of patients undergoing procedural interventions for SHD, including valve repair/replacement, cardiac surgery, drainage of pericardial effusion, or implanted defibrillator placement.
180 days post-index ED visit
Long-Term Medical Treatments for SHD
Time Frame: 1 year post-index ED visit

Number of patients who initiated new cardiovascular medications (e.g., antihypertensives, diuretics) for treatment of structural heart disease within 1 year.
1 year post-index ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pierre Elias

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Edwards Lifesciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre Elias, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAU9699
  • 1R01HL177055-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data (IPD) from this study will not be shared. The data contain protected health information (PHI) from electronic health records (EHR) and are linked to specific patients and providers. Sharing this information could risk patient privacy and confidentiality, even with de-identification. Additionally, the data are collected under institutional policies and HIPAA regulations that restrict external access.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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