Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorPierre Elias
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
40 years of age or older
Received an ECG upon presentation to the Emergency Department
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
EHR Alert
DeviceEKG Algorithm to identify structural heart disease
Treatment groups
4,000 Participants
are divided into 2 treatment groupsGroup A: Standard Treatment - No EHR AlertNo intervention 0 interventions
Group B: Intervention - EHR Alert & Community Tele-paramedicineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of new diagnoses of Structural Heart Disease (SHD)
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.
Time frame
180 days post index ED visitSecondary outcomes
1
Rate of echocardiography ordering
Proportion of patients who received an echocardiogram following the index ED visit.
Time frame
180 days post index ED visit2
New Medical Treatments for SHD
Number of patients initiating new cardiovascular medications (e.g., antihypertensives, diuretics) specifically for treatment of structural heart disease.
Time frame
180 days post index ED visit3
New Surgical or Procedural Interventions for SHD
Number of patients undergoing procedural interventions for SHD, including valve repair/replacement, cardiac surgery, drainage of pericardial effusion, or implanted defibrillator placement.
Time frame
180 days post-index ED visit4
Long-Term Medical Treatments for SHD
Number of patients who initiated new cardiovascular medications (e.g., antihypertensives, diuretics) for treatment of structural heart disease within 1 year.
Time frame
1 year post-index ED visitSponsors and contacts
Click on the lead sponsor to view all of their trials.
Pierre Elias
Lead sponsor
Columbia University
Sponsor institution
Edwards Lifesciences
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov