Recruiting

EchoNext

Sponsor:

Pierre Elias

Code:

NCT07843004

Conditions

Structural Heart Abnormality

Valve Heart Disease

Heart Diseases

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

EHR Alert

Study Details

Brief summary:

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.

Conditions

Structural Heart Abnormality

Valve Heart Disease

Heart Diseases

Cardiovascular Diseases

Study ID

NCT07843004

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

4000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

EHR Alert

EKG Algorithm to identify structural heart disease

Primary outcome measure

  • Number of new diagnoses of Structural Heart Disease (SHD) [ Time Frame: 180 days post index ED visit ]

Central Contacts and Locations

Central contacts

Michelle S Castillo, MS

7322777644mc5067@cumc.columbia.edu

Locations

Columbia University Irving Medical Center / NewYork-Presbyterian

Recruiting

New York, New York, United States, 10032

Contacts

Michelle Castillo, MS

732-277-7644mc5067@cumc.columbia.edu

Principal Investigator:

Pierre Elias, MD

More Information

Sponsor

Pierre Elias

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Structural Heart Disease
  • Heart Disease
  • Machine Learning
  • Electrocardiogram
  • artificial intelligence
  • echocardiogram
  • electronic health record
  • emergency department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Pierre Elias on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.