4000 Participants NeededMy employer runs this trial

EHR Alert for Heart Disease

(CACTUS Trial)

MS
Overseen ByMichelle S Castillo, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Pierre Elias
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

PE

Pierre Elias, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for adults who come to the Emergency Department and have an ECG done. It focuses on people who might have hidden heart problems like weak heart pumping or valve issues, but does not specify other inclusion or exclusion criteria.

Inclusion Criteria

Received an ECG upon presentation to the Emergency Department
I am 40 years old or older.

Exclusion Criteria

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
Had an echocardiogram within the prior 2 years
See 1 more

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing if using EchoNext, an AI tool that analyzes ECGs and sends alerts to doctors about possible structural heart disease, helps find these conditions earlier compared to usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Intervention - EHR Alert & Community Tele-paramedicineExperimental Treatment1 Intervention
Group II: Standard Treatment - No EHR AlertActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Pierre Elias

Lead Sponsor

Trials
1
Recruited
100+

Edwards Lifesciences

Industry Sponsor

Trials
188
Recruited
67,500+
Founded
1958
Headquarters
Irvine, California, U.S.
Known For
Structural Heart Innovations
Top Products
SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3
Todd Brinton profile image

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian profile image

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+