Chest PainPhase 4NCT07074808
RCT aiTriage Chest Pain Risk Stratification
A Phase 4 study testing aiTriage risk score in people with Chest Pain and Emergencies, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
Chest pain is one of the most common reasons people visit the Emergency Department (ED). While most cases are not serious, a small number may lead to life-threatening heart problems, known as Major Adverse Cardiac Events (MACE). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chest Pain, Emergencies
- What is being tested?
- aiTriage risk score
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,120 participants
- Where
- 2 sitesSingapore
- Study dates
- 11 Nov 2022to 29 Dec 2025
- Phase
- Phase 4
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ED patients (≥21 years old) with chest pain suspected of having ACS will be eligible for being included in this study.
Who cannot join
- Patients who are not in sinus rhythm
- Patients who do not have mental capacity.
- Patients with unstable vital signs, STEMI, obvious ACS, and non cardiac cases like rib fractures, pneumothorax.
- Patients lost to follow- up or transferred to other hospitals within the 30 day time frame.
- Patients with a high percentage of artefacts and ectopics exceeding 30% of ECG recordings will be excluded.
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
About this study
Official title: HRV Guided Accelerated Diagnostic Protocol for Chest Pain Patients - Randomised Control Trial (HRV-ADP RCT)
Chest pain is one of the most common reasons people visit the Emergency Department (ED). While most cases are not serious, a small number may lead to life-threatening heart problems, known as Major Adverse Cardiac Events (MACE). Emergency staff need to quickly identify these high-risk patients, but current methods often take time, involve lab tests, and strain already busy EDs.
In Singapore, for example, SGH sees over 120,000 ED patients a year. In the U.S., chest pain accounts for around 8-10 million ED visits annually, yet fewer than 10% are ultimately diagnosed with MACE. Still, over half of chest pain patients undergo extensive and costly testing, adding up to $10-13 billion each year. This over-testing is done to avoid missing a critical case, but it's inefficient and stressful for both staff and patients.
Read more
Traditional risk scoring tools like TIMI, GRACE, HEART, and EDACS require time and blood test results, delaying early intervention. Waiting times in EDs can be 1-2 hours, during which patient conditions may worsen unnoticed.
To address this, we've developed aiTriage, a portable device that uses AI to analyze heart rate variability, ECG readings, blood pressure, and oxygen levels. It provides a real-time risk score within 5 minutes, helping doctors decide which patients need urgent care. Unlike current methods, aiTriage works without waiting for lab tests and can ease the load on EDs.
No existing devices offer real-time MACE risk scoring like aiTriage. Our previous studies show that this system outperforms standard tools and could transform how chest pain is managed in emergency care, saving time, money, and lives.
Read the detailed description
Primary Aim
- To compare the admission rate defined as number of patients admitted/ all patients presenting to ED with chest pain (Inpatient admission or Emergency Observation Ward admission) of HRV guided accelerated diagnostic protocol (HRV-ADP) to the current standard protocol.
- To evaluate the implementation of HRV-ADP and understand the potential factors affecting implementation success in routine practice using the REAIM/PRISM framework
Secondary Aim
- To determine 30-day MACE between groups for discharged patients.
- To determine ED length of stay from registration to admission decision between groups.
- To calculate predicted aiTriage HRV-ADP admission rate vs actual (control group).
Primary Hypothesis - There will be a 10-20% reduction in admission rate with HRV-ADP comparing to the Standard protocol currently in practice.
Secondary Hypothesis
- There is no increase in Major Adverse Cardiac Events (MACE) between groups for discharged patients.
- Conditions
- Chest Pain, Emergencies
- Being tested
- aiTriage risk score
- Keywords
- Triage, emergency medicine, risk stratification, AI
- Medical subject headings
- Chest Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aiTriage risk scoreDevice
Risk score generated by AI App aiTriage for chest pain patients
| Study group | Role | What they receive |
|---|---|---|
| HRV-ADP | Experimental | Using aiTriage risk score for stratification Receives: Device: aiTriage risk score |
| Standard Control | No intervention | Standard control (no AI risk score) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission rate
[number of patients admitted] divided by [all patients presenting to ED with chest pain]
Measured: Throughout in ED, an average of 3 days
Secondary outcomes (3)
30-day MACE
Any major adverse cardiac events occurred in ED/hospital till discharged/death
Measured: 30 days starting from admission to ED
Hospital Length of Stay
From ED registration date/time to ward admission decision between groups
Measured: Within hospital stay, an average of 7 days
HRV-ADP Admission Rate
Admission rate (Intervention group vs Control Group)
Measured: within hospital stay, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start11 Nov 2022
- Primary completion30 Nov 2025
- Study completion29 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chest PainStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ADP vs Standard
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074808
- Sponsor's protocol ID
- CIRB 2022-2323
- Status last verified
- Jan 2026
- First submitted
- 29 Jun 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mahler SA, Burke GL, Duncan PW, Case LD, Herrington DM, Riley RF, Wells BJ, Hiestand BC, Miller CD. HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods. JMIR Res Protoc. 2016 Jan 22;5(1):e10. doi: 10.2196/resprot.4802.
PubMed 26800789Ong ME, Goh K, Fook-Chong S, Haaland B, Wai KL, Koh ZX, Shahidah N, Lin Z. Heart rate variability risk score for prediction of acute cardiac complications in ED patients with chest pain. Am J Emerg Med. 2013 Aug;31(8):1201-7. doi: 10.1016/j.ajem.2013.05.005. Epub 2013 Jun 10.
PubMed 23763936Wang Y, Li R, Pasupathi Y, Chan Y, Birthylon PI, Fook-Chong S, Zhang H, Lim SH, Kiat KTB, Basilio-Razon PI. Pilot Evaluation of a Novel Artificial Intelligence (AI) Heart Rate Variability (HRV)-Guided Risk Stratification for Chest Pain in the Emergency Department: A Randomized Controlled Trial. Clin Exp Emerg Med. 2026 Jul 27. doi: 10.15441/ceem.26.035. Online ahead of print.
PubMed 42509630
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HRV Guided Accelerated Diagnostic Protocol for Chest Pain Patients - Randomised Control Trial (HRV-ADP RCT)
- ClinicalTrials.gov ID
- NCT07074808
- Acronym / sponsor ID
- CIRB 2022-2323
- Conditions
- Chest Pain, Emergencies
- Keywords
- Triage, emergency medicine, risk stratification, AI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 29 Dec 2025 (actual)
- First posted
- 20 Jul 2025 (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.
Chest pain is one of the most common reasons people visit the Emergency Department (ED). While most cases are not serious, a small number may lead to life-threatening heart problems, known as Major Adverse Cardiac Events (MACE). Emergency staff need to quickly identify these high-risk patients, but current methods often take time, involve lab tests, and strain already busy EDs.
In Singapore, for example, SGH sees over 120,000 ED patients a year. In the U.S., chest pain accounts for around 8-10 million ED visits annually, yet fewer than 10% are ultimately diagnosed with MACE. Still, over half of chest pain patients undergo extensive and costly testing, adding up to $10-13 billion each year. This over-testing is done to avoid missing a critical case, but it's inefficient and stressful for both staff and patients.
Traditional risk scoring tools like TIMI, GRACE, HEART, and EDACS require time and blood test results, delaying early intervention. Waiting times in EDs can be 1-2 hours, during which patient conditions may worsen unnoticed.
To address this, we've developed aiTriage, a portable device that uses AI to analyze heart rate variability, ECG readings, blood pressure, and oxygen levels. It provides a real-time risk score within 5 minutes, helping doctors decide which patients need urgent care. Unlike current methods, aiTriage works without waiting for lab tests and can ease the load on EDs.
No existing devices offer real-time MACE risk scoring like aiTriage. Our previous studies show that this system outperforms standard tools and could transform how chest pain is managed in emergency care, saving time, money, and lives.
Detailed description
Primary Aim
- To compare the admission rate defined as number of patients admitted/ all patients presenting to ED with chest pain (Inpatient admission or Emergency Observation Ward admission) of HRV guided accelerated diagnostic protocol (HRV-ADP) to the current standard protocol.
- To evaluate the implementation of HRV-ADP and understand the potential factors affecting implementation success in routine practice using the REAIM/PRISM framework
Secondary Aim
- To determine 30-day MACE between groups for discharged patients.
- To determine ED length of stay from registration to admission decision between groups.
- To calculate predicted aiTriage HRV-ADP admission rate vs actual (control group).
Primary Hypothesis - There will be a 10-20% reduction in admission rate with HRV-ADP comparing to the Standard protocol currently in practice.
Secondary Hypothesis
- There is no increase in Major Adverse Cardiac Events (MACE) between groups for discharged patients.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- ADP vs Standard
| Arm | Type | Receives |
|---|---|---|
| HRV-ADP | Experimental | Device: aiTriage risk scoreUsing aiTriage risk score for stratification |
| Standard Control | No intervention | –Standard control (no AI risk score) |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All ED patients (≥21 years old) with chest pain suspected of having ACS will be eligible for being included in this study.
Key exclusion criteria (5 listed)
- Patients who are not in sinus rhythm
- Patients who do not have mental capacity.
- Patients with unstable vital signs, STEMI, obvious ACS, and non cardiac cases like rib fractures, pneumothorax.
- Patients lost to follow- up or transferred to other hospitals within the 30 day time frame.
- Patients with a high percentage of artefacts and ectopics exceeding 30% of ECG recordings will be excluded.
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 |
|---|---|---|
| aiTriage risk scoreRisk score generated by AI App aiTriage for chest pain patients | Device | HRV-ADP |
Primary outcome
Admission rate
Time frame: Throughout in ED, an average of 3 days
[number of patients admitted] divided by [all patients presenting to ED with chest pain]
3 secondary outcomes
30-day MACE
Time frame: 30 days starting from admission to ED
Hospital Length of Stay
Time frame: Within hospital stay, an average of 7 days
HRV-ADP Admission Rate
Time frame: within hospital stay, an average of 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 Jan 2026.
- Background: PubMed 26800789Mahler SA, Burke GL, Duncan PW, Case LD, Herrington DM, Riley RF, Wells BJ, Hiestand BC, Miller CD. HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods. JMIR Res Protoc. 2016 Jan 22;5(1):e10. doi: 10.2196/resprot.4802.
- Background: PubMed 23763936Ong ME, Goh K, Fook-Chong S, Haaland B, Wai KL, Koh ZX, Shahidah N, Lin Z. Heart rate variability risk score for prediction of acute cardiac complications in ED patients with chest pain. Am J Emerg Med. 2013 Aug;31(8):1201-7. doi: 10.1016/j.ajem.2013.05.005. Epub 2013 Jun 10.
- Derived from this study: PubMed 42509630Wang Y, Li R, Pasupathi Y, Chan Y, Birthylon PI, Fook-Chong S, Zhang H, Lim SH, Kiat KTB, Basilio-Razon PI. Pilot Evaluation of a Novel Artificial Intelligence (AI) Heart Rate Variability (HRV)-Guided Risk Stratification for Chest Pain in the Emergency Department: A Randomized Controlled Trial. Clin Exp Emerg Med. 2026 Jul 27. doi: 10.15441/ceem.26.035. Online ahead of print.
- aiTriage clinical trial in SingaporeLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing aiTriage risk score in people with Chest Pain and Emergencies, run by Singapore General Hospital at 2 sites in Singapore.
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 5 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Admission rate (time frame: Throughout in ED, an average of 3 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 NCT07074808, which also lists 3 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 Jan 2026.