Cardiovascular DiseasesNCT05118035
Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality
A study testing AI-enabled ECG-based Screening Tool in people with Cardiovascular Diseases and Intensity Care, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Intensity Care, Morality
- What is being tested?
- AI-enabled ECG-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,965 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients in emergency department or inpatient department.
- Patients recieved at least 1 ECG examination.
Who cannot join
- The patients recieved ECG at the period of inactive AI-ECG system.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality: a Pragmatic Randomized Clinical Trial
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.
- Conditions
- Cardiovascular Diseases, Intensity Care, Morality
- Being tested
- AI-enabled ECG-based Screening Tool
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enabled ECG-based Screening ToolOther
Primary care clinicians in the intervention group had access to the report, which shows the risk prediction results for each patients. Moreover, the clinicians will recieve a short message when patients with a high risk ECG identified by AI.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will have access to the screening tool. Once the AI-ECG indicates high risk of mortality, a warning message would be immediately triggered and sent to the corresponding attending physicians. Notifications appear in the recipient's smartphone message system for the prompt attention. The message notified the physician that, "An ECG was received for patient X. An ECG indicates high risk of mortality. Please intensively attend to patient's conditions. If the physicians need to further identify the ECG, click on the following link to connect the ECG and the result of AI-ECG prediction." Of note, although we will actively send a warning message for high risk cases, the AI-ECG report for low risk cases still presented the degree of risk. Physicians can check the relative severity by access EHR for patients in the intervention group. Receives: Other: AI-enabled ECG-based Screening Tool |
| Control | No intervention | Patients will continue routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality (death)
After performing an electrocardiogram, the patient's survival is tracked.
Measured: Within 90 days
Secondary outcomes (4)
Cardiovascular cause mortality (death)
After performing an electrocardiogram, the patient's survival is tracked.
Measured: Within 90 days
Arrhythmia medication
After performing an electrocardiogram, the patient recieved related intervention.
Measured: Within 12 hours
Electrolyte examination
After performing an electrocardiogram, the patient recieved electrolyte examination
Measured: Within 3 days
Cadiac examination
After performing an electrocardiogram, the patient recieved cadiac examination
Measured: Within 3-7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start15 Dec 2021
- Primary completion30 Apr 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- intervention group:8001 control group:7964
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15,965 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chin Lin, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118035
- Sponsor's protocol ID
- NDMC2021005
- Status last verified
- Feb 2023
- First submitted
- 1 Nov 2021
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hsieh PH, Lin C, Lin CS, Liu WT, Lin TK, Tsai DJ, Hung YJ, Chen YH, Lin CY, Lin SH, Tsai CS. Economic analysis of an AI-enabled ECG alert system: impact on mortality outcomes from a pragmatic randomized trial. NPJ Digit Med. 2025 Jun 11;8(1):348. doi: 10.1038/s41746-025-01735-7.
PubMed 40494963Lin CS, Liu WT, Tsai DJ, Lou YS, Chang CH, Lee CC, Fang WH, Wang CC, Chen YY, Lin WS, Cheng CC, Lee CC, Wang CH, Tsai CS, Lin SH, Lin C. AI-enabled electrocardiography alert intervention and all-cause mortality: a pragmatic randomized clinical trial. Nat Med. 2024 May;30(5):1461-1470. doi: 10.1038/s41591-024-02961-4. Epub 2024 Apr 29.
PubMed 38684860
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying an Artificial Intelligence-Enabled Electrocardiographic System for Reducing Mortality: a Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05118035
- Acronym / sponsor ID
- NDMC2021005
- Conditions
- Cardiovascular Diseases, Intensity Care, Morality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,965 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for early detection of clinical deterioration for reducing mortality.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- intervention group:8001 control group:7964
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AI-enabled ECG-based Screening ToolPatients randomized to intervention will have access to the screening tool. Once the AI-ECG indicates high risk of mortality, a warning message would be immediately triggered and sent to the corresponding attending physicians. Notifications appear in the recipient's smartphone message system for the prompt attention. The message notified the physician that, "An ECG was received for patient X. An ECG indicates high risk of mortality. Please intensively attend to patient's conditions. If the physicians need to further identify the ECG, click on the following link to connect the ECG and the result of AI-ECG prediction." Of note, although we will actively send a warning message for high risk cases, the AI-ECG report for low risk cases still presented the degree of risk. Physicians can check the relative severity by access EHR for patients in the intervention group. |
| Control | No intervention | –Patients will continue routine practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients in emergency department or inpatient department.
- Patients recieved at least 1 ECG examination.
Key exclusion criteria (1 listed)
- The patients recieved ECG at the period of inactive AI-ECG system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-enabled ECG-based Screening ToolPrimary care clinicians in the intervention group had access to the report, which shows the risk prediction results for each patients. Moreover, the clinicians will recieve a short message when patients with a high risk ECG identified by AI. | Other | Intervention |
Primary outcome
All cause mortality (death)
Time frame: Within 90 days
After performing an electrocardiogram, the patient's survival is tracked.
4 secondary outcomes
Cardiovascular cause mortality (death)
Time frame: Within 90 days
Arrhythmia medication
Time frame: Within 12 hours
Electrolyte examination
Time frame: Within 3 days
Cadiac examination
Time frame: Within 3-7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 40494963Hsieh PH, Lin C, Lin CS, Liu WT, Lin TK, Tsai DJ, Hung YJ, Chen YH, Lin CY, Lin SH, Tsai CS. Economic analysis of an AI-enabled ECG alert system: impact on mortality outcomes from a pragmatic randomized trial. NPJ Digit Med. 2025 Jun 11;8(1):348. doi: 10.1038/s41746-025-01735-7.
- Derived from this study: PubMed 38684860Lin CS, Liu WT, Tsai DJ, Lou YS, Chang CH, Lee CC, Fang WH, Wang CC, Chen YY, Lin WS, Cheng CC, Lee CC, Wang CH, Tsai CS, Lin SH, Lin C. AI-enabled electrocardiography alert intervention and all-cause mortality: a pragmatic randomized clinical trial. Nat Med. 2024 May;30(5):1461-1470. doi: 10.1038/s41591-024-02961-4. Epub 2024 Apr 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enabled ECG-based Screening Tool in people with Cardiovascular Diseases and Intensity Care, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (death) (time frame: Within 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05118035, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.