Left Ventricular Systolic Dysfunction (Disorder)NCT05117970
Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
A study testing AI-enabled ECG-based Screening Tool in people with Left Ventricular Systolic Dysfunction (Disorder), 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 improving the diagnosis and management of left ventricular systolic dysfunction. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Left Ventricular Systolic Dysfunction (Disorder)
- What is being tested?
- AI-enabled ECG-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13,631 participants
- Where
- 1 siteTaiwan
- Study dates
- 9 Dec 2021to 31 Dec 2023
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with EF>50% or without Transesophageal Echocardiography (TEE)
Who cannot join
- Patients with a history of heart failure or an EF<= 35%.
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial (RCT) to test a novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
- Being tested
- AI-enabled ECG-based Screening Tool
- Medical subject headings
- Ventricular Dysfunction, Left
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 displayed whether the AI-ECG result was positive or negative.The system will send a message to corresponding physicians if positive finding.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients randomized to intervention will have access to the screening tool. Receives: Other: AI-enabled ECG-based Screening Tool |
| Control | No intervention | Patients randomized to control will continue routine practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)
Ejection fraction obtained by echocardiography
Measured: Within 30 days
Secondary outcomes (2)
All cause mortality(death)
After performing an electrocardiogram, the patient's survival is tracked.
Measured: Within 30 days
Completion of an echocardiogram
After performing the ECG examination, perform the echocardiogram examination
Measured: Within 30 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 start9 Dec 2021
- Primary completion31 May 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular Systolic Dysfunction (Disorder)Studies 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
- Masking
- None (open label)
- Enrolment
- 13,631 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
- NCT05117970
- Sponsor's protocol ID
- NDMC2021001
- Status last verified
- Oct 2024
- First submitted
- 1 Nov 2021
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tsai DJ, Lin C, Liu WT, Lee CC, Chang CH, Lin WY, Liu YL, Chang DW, Hsieh PH, Tsai CS, Chen YH, Hung YJ, Lin CS. Artificial intelligence-assisted diagnosis and prognostication in low ejection fraction using electrocardiograms in inpatient department: a pragmatic randomized controlled trial. BMC Med. 2025 Jun 9;23(1):342. doi: 10.1186/s12916-025-04190-z.
PubMed 40484925
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-assisted Diagnosis and Prognostication in Low Ejection Fraction Using Electrocardiograms
- ClinicalTrials.gov ID
- NCT05117970
- Acronym / sponsor ID
- NDMC2021001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13,631 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 31 Dec 2023 (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 improving the diagnosis and management of left ventricular systolic dysfunction.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: AI-enabled ECG-based Screening ToolPatients randomized to intervention will have access to the screening tool. |
| Control | No intervention | –Patients randomized to control will continue routine practice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with EF>50% or without Transesophageal Echocardiography (TEE)
Key exclusion criteria (1 listed)
- Patients with a history of heart failure or an EF<= 35%.
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 displayed whether the AI-ECG result was positive or negative.The system will send a message to corresponding physicians if positive finding. | Other | Intervention |
Primary outcome
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%)
Time frame: Within 30 days
Ejection fraction obtained by echocardiography
2 secondary outcomes
All cause mortality(death)
Time frame: Within 30 days
Completion of an echocardiogram
Time frame: Within 30 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 23 Oct 2024.
- Derived from this study: PubMed 40484925Tsai DJ, Lin C, Liu WT, Lee CC, Chang CH, Lin WY, Liu YL, Chang DW, Hsieh PH, Tsai CS, Chen YH, Hung YJ, Lin CS. Artificial intelligence-assisted diagnosis and prognostication in low ejection fraction using electrocardiograms in inpatient department: a pragmatic randomized controlled trial. BMC Med. 2025 Jun 9;23(1):342. doi: 10.1186/s12916-025-04190-z.
- 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 Left Ventricular Systolic Dysfunction (Disorder), 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 1 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 23 Oct 2024. 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?
New Diagnosis of Low Ejection Fraction(defined as ejection fraction ≤50%) (time frame: Within 30 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 NCT05117970, which also lists 1 linked publication.
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 23 Oct 2024.