Harnessing ECG Artificial Intelligence for Rapid Treatment and Accurate Identification of Structural Heart Disease
NCT ID: NCT06462989
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
16160 participants
INTERVENTIONAL
2025-04-16
2027-01-31
Brief Summary
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Our primary objective is to assess the impact of displaying the ECHONeXT interpretation on 12-lead ECGs on the time to diagnosis of Structural Heart Disease (SHD) among newly referred patients at MHI. We will compare the time interval from the initial ECG to SHD diagnosis by transthoracic echocardiogram (TTE) or magnetic resonance imaging (MRI) between patients in the intervention arm (where ECHONeXT prediction of SHD and TTE priority recommendation are displayed) and patients in the control arm (where ECHONeXT prediction and recommendation are hidden).
The main secondary objective is to evaluate the rate of SHD detection on TTE or MRI among newly referred patients. We also aim to assess the delay between the time of the first ECG opened in the platform and the TTE or MRI evaluation among newly referred patients at high or intermediate risk of SHD.
By integrating an AI-analysis platform at the point of care and evaluating its impact on ECG interpretation accuracy and prioritization of incremental tests, the HEART-AI study aims to provide valuable insights into the potential of AI in improving cardiac care and patient outcomes.
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Detailed Description
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We will achieve this by comparing the time between the first ECG and diagnosis of SHD on TTE or MRI between the intervention group, where the ECHONeXT interpretation is displayed to users, and the control group, where it is not displayed, thereby quantifying the influence of AI-supported diagnostics on clinical decision-making and patient management strategies.
For the purpose of the study, SHD will be defined as presence of any of the following on TTE or MRI:
* LVEF ≤ 45%
* Mild, moderate or severe RV Dysfunction
* The presence of one or multiple valvulopathies in this list:
* Moderate-to-severe pulmonary regurgitation
* Moderate-to-severe tricuspid regurgitation
* Moderate-to-severe mitral regurgitation
* Moderate-to-severe aortic regurgitation
* Moderate-to-severe aortic stenosis
* Moderate or severe pericardial effusion (Tamponade or any effusion \> 1 cm)
* LV wall thickness ≥ 1.3 cm
* Apical cardiomyopathy
* Pulmonary hypertension as defined using the systolic pressure of the pulmonary artery greater or equal to 25 mm Hg on TTE.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ECHONEXT interpretation
The ECHONeXT algorithm was trained to predict the presence of SHD on TTE using a single 12-lead ECG. It was developed at Columbia hospital, released as open-weights and validated at the MHI. It was trained on 800,000 ECG and TTE pairs.
ECHONEXT
ECHONEXT Artificial intelligence algorithm
No ECHONEXT interpretation
Not displaying the ECHONEXT algorithm interpretation.
No interventions assigned to this group
Interventions
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ECHONEXT
ECHONEXT Artificial intelligence algorithm
Eligibility Criteria
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Inclusion Criteria
1. Users who are providing clinical care and who read ECGs as part of their practice.
2. Users who have provided informed consent to participate in the study.
3. Users who have completed the required training on the use of the DeepECG platform.
ECG
1. 12-lead ECGs recorded during the study period at the Montreal Heart Institute.
2. ECGs of adequate technical quality for interpretation, as determined by the recording software and visual inspection.
Patients
1\. Patients aged 18 years or older
1. Outpatients or patients who presented at the ambulatory emergency department. The location will be determined according to the ECG where it was recorded which is entered by the ECG technician. These locations will be included for the eligibility of the randomization:
a. locations\_to\_keep = \['21\_URGENCE AMBULATOIRE', '1\_CARDIOLOGIE GENERALE', "17\_CLINIQUE D'ARYTHMIE"\]
2. New patients without a prior formal evaluation by a cardiologist or internal medicine specialist for suspected or provisionally identified cardiac conditions, including:
1. Arrhythmia
2. Heart Failure
3. Coronary Artery Disease
4. Valvular Heart Disease
5. Cardiomyopathy
6. Other cardiac conditions
3. Patients with previous TTE or MRI:
1. Have no documented history of any cardiac condition
2. No transthoracic echocardiogram or MRI in the last 24 months (from any center)
Exclusion Criteria
1\. Users who are unable to commit to the duration of the study (approximately 1 month minimum) or adhere to the study protocol.
1\. ECG with too many artefacts or without any QRS visible as interpretated by the MUSE GE algorithm.
18 Years
ALL
No
Sponsors
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Montreal Heart Institute
OTHER
Responsible Party
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Robert Avram
Interventional Cardiologist
Locations
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Montreal Heart Institute
Montreal, Quebec, Canada
Countries
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Related Links
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Related Info
Other Identifiers
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HEART-AI-001
Identifier Type: -
Identifier Source: org_study_id
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