This study aims to validate the use of an artificial intelligence-enabled electrocardiogram (AI-ECG) to screen for elevated PAP. We hypothesize that the AI-ECG model can early identify patients with pulmonary hypertension in high-risk patients, prompting further evaluation through echocardiography, potentially resulting in improving cardiovascular outcomes.
Pulmonary hypertension is often underdiagnosed due to extensive category of etiology. The diagnosis and treatment of pulmonary hypertension have changed dramatically through the re-defined diagnostic criteria and advanced drug development in the past decade. The application of Artificial Intelligence for the detection of elevated pulmonary arterial pressure (ePAP) was reported recently. An AI model based on electrocardiograms (ECG) has shown promise in not only detecting ePAP but also in predicting future risks related to cardiovascular mortality.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
8,666
Participants undergo screening using the AI-ECG system. Those identified as high-risk for pulmonary hypertension receive echocardiography to confirm the diagnosis and guide subsequent management.
National Defense Medical Center
Taipei, Taiwan
RECRUITINGPulmonary arterial pressure > 50 mmHg
The composite endpoint is defined as detecting pulmonary hypertension \> 50mmHg by echocardiography, indicating high risk for pulmonary hypertension.
Time frame: 90 days
Left atrial enlargement on a parasternal long axis view
The endpoint measures the size of left atrium \> 40mm on a parasternal long axis view by echocardiography.
Time frame: Within 90 days after randomization.
Left atrial enlargement by left atrium volume index
The endpoint measures the size of left atrium volume index \> 29 mL/m2 in sinus rhythm or \> 40 mL/m2 in AF by echocardiography.
Time frame: Within 90 days after randomization.
Right ventricular enlargement on a parasternal long axis view
The endpoint measures the size of right ventricular basal dimension \> 27mm by echocardiography.
Time frame: Within 90 days after randomization.
New onset of left ventricular dysfunction
The endpoint measures the number and proportion of LVEF \< 50%.
Time frame: Within 90 days after randomization.
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