RecruitingNot ApplicableNCT07079592

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension: A Randomized Controlled Trial


Sponsor

National Defense Medical Center, Taiwan

Enrollment

8,666 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Inclusion Criteria2

  • Men or women, ≥ 50 to 85 years of age
  • At least one 12-lead ECG within 3 months

Exclusion Criteria5

  • A diagnosis of PH WHO Groups 1, 2, 3, 4, or 5
  • A diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, cardiac amyloidosis, or infiltrative cardiomyopathy
  • Prior heart, lung, or heart-lung transplants
  • Any systolic pulmonary artery pressure \>50 mmHg by echocardiography before
  • Echocardiography in 3 months before index ECG

Interventions

DIAGNOSTIC_TESTAI-ECG Guidance

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.


Locations(1)

National Defense Medical Center

Taipei, Taiwan

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NCT07079592


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