Atrial Fibrillation New OnsetNCT05127460
CARDIOLOGIST Trial: Artificial Intelligence Enabled Electrocardiogram for Atrial Fibrillation Detection
A study testing AI-enabled ECG-based Screening Tool in people with Atrial Fibrillation New Onset, 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 Atrial Fibrillation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- AI-enabled ECG-based Screening Tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25,732 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 31 Jan 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 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 had at least 1 ECG
- Patients cared by non-cardiologist
Who cannot join
- Patients without history of atrial fibrillation diagnosis.
- Patients without history of long-term NOAC or warfarin usage.
- Patients without history of hemorrhagic stoke or ishemic stroke.
- Patients with low eGFR (<30 ml/min)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-assisted Atrial Fibrillation Risk Detection In Oral-anticoagulant Use, Lowering Stroke Risk, and Optimizing Guidance With an Intelligent Screening Tool (CARDIOLOGIST): a Pragmatic Randomized Controlled Trial
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 Atrial Fibrillation.
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- AI-enabled ECG-based Screening Tool
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.
Proportion of taking AF treatment medications
defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).
Measured: Within 90 days
Proportion of ischemic Stroke
After performing an electrocardiogram, the patient's physical conditions is tracked.
Measured: Within 90 days
Secondary outcomes (7)
Proportion of cardiologist consultation
Cardiovascular outpatient visit after discovering atrial fibrillation.
Measured: Within 90 days
Proportion of new-onset AF diagnosis
Atrial fibrillation diagnosis in medical records
Measured: Within 90 days
Proportion of echocardiogram performed after ECGs
After performing the ECG examination, perform the echocardiography examination.
Measured: Within 90 days
Proportion of new-onset heart failure
After performing an electrocardiogram, the patient's medical record is tracked.
Measured: Within 90 days
Proportion of gastrointestinal bleeding
After performing an electrocardiogram, the patient's medical record is tracked.
Measured: Within 90 days
Proportion of hemorrhagic stroke
After performing an electrocardiogram, the patient's medical record is tracked.
Measured: Within 90 days
Proportion of all cause mortality(death)
After performing an electrocardiogram, the patient's survival is tracked.
Measured: Within 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Jan 2022
- Primary completion31 Oct 2022
- Study completion31 Jan 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 Atrial Fibrillation New OnsetStudies 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
- 25,732 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
- NCT05127460
- Sponsor's protocol ID
- NDMC2021002
- Status last verified
- Mar 2023
- First submitted
- 1 Nov 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu WT, Lin C, Lee CC, Chang CH, Fang WH, Tsai DJ, Lin WY, Hung Y, Chen KC, Lee CH, Tsai TN, Lin WS, Hung YJ, Lin SH, Tsai CS, Lin CS. Artificial Intelligence-Enabled ECGs for Atrial Fibrillation Identification and Enhanced Oral Anticoagulant Adoption: A Pragmatic Randomized Clinical Trial. J Am Heart Assoc. 2025 Jul 15;14(14):e042106. doi: 10.1161/JAHA.125.042106. Epub 2025 Jul 3.
PubMed 40611485
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-assisted Atrial Fibrillation Risk Detection In Oral-anticoagulant Use, Lowering Stroke Risk, and Optimizing Guidance With an Intelligent Screening Tool (CARDIOLOGIST): a Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05127460
- Acronym / sponsor ID
- NDMC2021002
- Conditions
- Atrial Fibrillation New Onset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25,732 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 19 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 Atrial Fibrillation.
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
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients in emergency department or inpatient department
- Patients had at least 1 ECG
- Patients cared by non-cardiologist
Key exclusion criteria (4 listed)
- Patients without history of atrial fibrillation diagnosis.
- Patients without history of long-term NOAC or warfarin usage.
- Patients without history of hemorrhagic stoke or ishemic stroke.
- Patients with low eGFR (<30 ml/min)
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
Proportion of taking AF treatment medications
Time frame: Within 90 days
defined as use of long-term NOAC (apixaban, rivaroxaban, endoxaban, dabigatran).
Proportion of ischemic Stroke
Time frame: Within 90 days
After performing an electrocardiogram, the patient's physical conditions is tracked.
7 secondary outcomes
Proportion of cardiologist consultation
Time frame: Within 90 days
Proportion of new-onset AF diagnosis
Time frame: Within 90 days
Proportion of echocardiogram performed after ECGs
Time frame: Within 90 days
Proportion of new-onset heart failure
Time frame: Within 90 days
Proportion of gastrointestinal bleeding
Time frame: Within 90 days
Proportion of hemorrhagic stroke
Time frame: Within 90 days
Proportion of all cause mortality(death)
Time frame: Within 90 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 28 Mar 2023.
- Derived from this study: PubMed 40611485Liu WT, Lin C, Lee CC, Chang CH, Fang WH, Tsai DJ, Lin WY, Hung Y, Chen KC, Lee CH, Tsai TN, Lin WS, Hung YJ, Lin SH, Tsai CS, Lin CS. Artificial Intelligence-Enabled ECGs for Atrial Fibrillation Identification and Enhanced Oral Anticoagulant Adoption: A Pragmatic Randomized Clinical Trial. J Am Heart Assoc. 2025 Jul 15;14(14):e042106. doi: 10.1161/JAHA.125.042106. Epub 2025 Jul 3.
- 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 Atrial Fibrillation New Onset, 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 3 inclusion and 4 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 28 Mar 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?
Proportion of taking AF treatment medications (time frame: Within 90 days). The study lists 2 primary outcomes in all. 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 NCT05127460, 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 28 Mar 2023.