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AI reads your Heart's future: new software predicts 1-Year mortality risk from a simple ECG

NCT ID NCT07659262

Diagnosis Sponsor: National Defense Medical Center, Taiwan Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an artificial intelligence software that analyzes a standard 10-second ECG to predict the risk of dying from heart disease within one year. Researchers reviewed ECG data from over 460,000 patients across three hospitals in Taiwan. The goal was to see if the AI could accurately identify high-risk patients, potentially helping doctors make better decisions about long-term care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Chang Gung ECG Mortality Risk Prediction Software (AI software analyzing ECG signals)
What this could lead to
If successful, this AI tool could help doctors quickly identify patients at high risk of dying from heart disease within a year, enabling earlier intervention.
What could go wrong
This is a retrospective study, not a prospective trial, so real-world performance may differ. The AI was tested only in Taiwan, so results may not apply to other populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

461,982 people

The number who actually took part.

Started

Apr 2025

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population consists of adult patients (aged 20 years and older) with suspected cardiovascular disease who underwent standard 12-lead resting electrocardiogram (ECG) examinations. Data will be retrospectively collected from three medical institutions in Taiwan-Tri-Service General Hospital, Kaohsiung Armed Forces General Hospital, and Taipei Municipal Wanfang Hospital-between August 2011 and September 2024. The study population represents a diverse real-world patient population across multiple clinical settings, including outpatient clinics, inpatient wards, and emergency departments, with comprehensive documentation of clinical diagnoses and one-year mortality outcomes.

Ages

20 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 20 years and older. * Patients who underwent a 12-lead resting electrocardiogram (ECG). * ECG records must meet the software input specifications: 12 leads, a sampling rate of 500 Hz, a 60-Hz Alternating Current (AC) filter, a recording duration of 10 seconds, and Extensible Markup Language (XML) file format. * Only the first eligible 12-lead ECG record from each patient will be included to avoid intra-individual bias. Exclusion Criteria: * ECG records with missing leads. * Cases with missing demographic information (e.g., age, sex, or mortality status) or incomplete clinical diagnostic data. * ECG records that do not meet the software input specifications (e.g., an incorrect sampling rate, AC filter setting, recording duration, or file format). * Pregnant women and patients with implanted pacemakers..

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Electrocardiogram Mortality risk prediction

Contacts and locations

Locations

  • Kaohsiung Armed Forces General Hospital

    Kaohsiung City, 807, Taiwan

  • Taipei Municipal Wanfang Hospital

    Taipei, 114, Taiwan

  • Tri-Service General Hospital

    Taipei, 114, Taiwan

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