NCT07843004 · Pierre Elias
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
(CACTUS)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
EHR Alert
EKG Algorithm to identify structural heart disease
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
Edwards Lifesciences, National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 25, 2026 · Source of record for eligibility and locations