STEMI - ST-segment Elevation Myocardial InfarctionSMART-CART-AMINCT07780942
SMARTwatch for the Diagnosis of ST-segment Elevation Myocardial Infarction in Patients With Chest Pain
An observational study of STEMI - ST-segment Elevation Myocardial Infarction and Chest Pain, run by Hospital General Universitario Santa Lucia at 1 site in Spain.
Trial summary
The main symptom that initiates the diagnostic and therapeutic process for patients with suspected acute coronary syndrome is chest pain. Based on a standard 12-lead electrocardiogram (ECG), patients can be diagnosed with ST-segment elevation myocardial infarction (STEMI), which requires immediate medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST-segment Elevation Myocardial Infarction, Chest Pain
- What is being tested?
- ECG smartwatch recording
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 14 Aug 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: The study population consists of unselected patients presenting to the Emergency Department at Hospital Universitario Santa Lucía (Cartagena) who are evaluated by the on-call cardiologist for ischemic-profile chest pain. This represents a real-world clinical cohort in an acute setting. Patients with extreme hemodynamic instability (where an additional recording would delay critical emergency treatment) and those with baseline electrocardiogram alterations (such as prior left bundle branch block or pacemaker-mediated pacing) that preclude proper ST-segment interpretation are excluded from this population.
Who may be able to join
- Patients evaluated by the on-call cardiologist for chest pain with an ischemic profile.
Who cannot join
- Patients with extreme hemodynamic instability where the additional recording would cause an ethically unacceptable delay in their treatment.
- Patients with a prior diagnosis of left bundle branch block or pacemaker-mediated pacing.
- Patients who decline participation in the registry.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital General Universitario Santa Lucia
Cartagena, Murcia, 30202
Eulalia Gómez Sannicolás, (+34) 968 110 752, investigacionarea2-sms@carm.es
Juan A Castillo Moreno, MD, PhD, jacastillomo@gmail.com
About this study
Official title: Observational and Prospective Diagnostic Validation Study of the SMARTwatch for ST-segment Elevation Myocardial Infarction in Health Area of Cartagena
The main symptom that initiates the diagnostic and therapeutic process for patients with suspected acute coronary syndrome is chest pain. Based on a standard 12-lead electrocardiogram (ECG), patients can be diagnosed with ST-segment elevation myocardial infarction (STEMI), which requires immediate medical treatment. Recently, wearable devices like smartwatches with ECG capabilities have opened new pathways for cardiac triage, but their diagnostic precision and technical viability in a real, unselected Emergency Department setting need to be confirmed.
The primary objective of this prospective, observational study is to compare the diagnostic capacity of a 9-lead ECG obtained with a smartwatch against the standard 12-lead ECG for diagnosing STEMI in patients consulting for chest pain.
Read more
During the study, patients evaluated by the on-call cardiologist for ischemic chest pain will undergo their standard care. In addition to the standard 12-lead ECG, a 9-lead ECG will be sequentially recorded using a smartwatch. This is an observational study, meaning the smartwatch recording will not cause any delay in clinical action or negatively impact the patient's standard treatment.
Specifically, the study aims to:
- Analyze the diagnostic agreement between expert cardiologists when blindly and independently classifying the smartwatch recordings versus the standard ECG recordings as "STEMI" or "non-STEMI".
- Evaluate the technical feasibility of using the smartwatch in an Emergency Department setting by assessing the percentage of unreadable records due to artifacts.
Read the detailed description
Background and Rationale:
The clinical spectrum of acute coronary syndrome (ACS) is broad, with chest pain being the primary symptom initiating the diagnostic and therapeutic cascade. In patients with ST-segment elevation myocardial infarction (STEMI), immediate reperfusion -primarily via percutaneous coronary intervention (PCI)-is crucial. While primary PCI has significantly reduced mortality, minimizing systemic delays remains vital.
Recently, wearable devices with electrocardiographic (ECG) capabilities have emerged as potential tools for ultra-early cardiac triage. Previous research, such as the SMARTAMI study, demonstrated that a sequential 9-lead smartwatch ECG has high sensitivity and specificity for detecting STEMI. However, these prior studies often compared confirmed myocardial infarction cases with healthy, asymptomatic cohorts in highly controlled environments. There is a critical need to validate the technical feasibility, signal quality, and diagnostic accuracy of this technology in a real-world Emergency Department (ED) setting with unselected patients, where factors like diaphoresis, acute pain, and time urgency complicate the recording process.
Study Design and Clinical Procedures:
This is a prospective, observational diagnostic validation and concordance study conducted in a real-world clinical setting. Patients evaluated by the on-call cardiologist for ischemic-profile chest pain will be consecutively enrolled. The study is purely observational; obtaining the smartwatch ECG will not delay standard clinical care, and standard medical management will remain unaltered.
Following standard protocols, an analog sequential 9-lead ECG (I, II, III, V1-V6) will be recorded using a smartwatch alongside the standard 12-lead ECG.
Blinding and Data Evaluation:
A rigorous double-blind, independent analysis will be performed. The on-call cardiologists responsible for acquiring the tracings in the ED will not participate in their interpretation. Both the standard 12-lead ECGs and the smartwatch ECGs will be completely anonymized using unique alphanumeric codes. Subsequently, independent expert cardiologists will blindly evaluate the tracings, classifying them as "STEMI" or "non-STEMI" without any knowledge of the patient's clinical data or the origin of each specific recording.
Statistical Approach and Sample Size:
Based on prior literature in controlled settings reporting a 93% sensitivity, this real-world study conservatively estimates an 85% expected sensitivity due to ED-specific variables (e.g., signal noise, diaphoresis). To achieve a 10% margin of error with a 95% confidence level, a sample size of 49 confirmed STEMI positive cases is required. Consecutive recruitment will continue uninterrupted until this target is reached. Patients enrolled during this period who are ultimately diagnosed as "non-STEMI" will be retained in the database to calculate the specificity of the device.
- Being tested
- ECG smartwatch recording
- Keywords
- ST Elevation Myocardial Infarction, Chest Pain, Smartwatch, Wearables, Electrocardiography
- Medical subject headings
- Chest Pain, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG smartwatch recordingDiagnostic test
Recording a 9-lead ECG with a smartwatch
| Study group | Role | What they receive |
|---|---|---|
| General cohort | Not described Receives: Diagnostic Test: ECG smartwatch recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartwatch ECG records' ability to diagnose STEMI
Analyze the diagnostic agreement between expert cardiologists when blindly and independently classifying the smartwatch recordings versus the standard ECG recordings as "STEMI" or "non-STEMI".
Measured: From enrollment to the blinded analysis at the end of the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start14 Aug 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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 STEMI - ST-segment Elevation Myocardial InfarctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Buendia Santiago, Hospital General Universitario Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780942
- Sponsor's protocol ID
- I-AREA2_26-68_SMART-CART-AMI
- Acronym
- SMART-CART-AMI
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Spaccarotella CAM, Polimeni A, Migliarino S, Principe E, Curcio A, Mongiardo A, Sorrentino S, De Rosa S, Indolfi C. Multichannel Electrocardiograms Obtained by a Smartwatch for the Diagnosis of ST-Segment Changes. JAMA Cardiol. 2020 Oct 1;5(10):1176-1180. doi: 10.1001/jamacardio.2020.3994.
PubMed 32865545
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational and Prospective Diagnostic Validation Study of the SMARTwatch for ST-segment Elevation Myocardial Infarction in Health Area of Cartagena
- ClinicalTrials.gov ID
- NCT07780942
- Acronym / sponsor ID
- SMART-CART-AMI / I-AREA2_26-68_SMART-CART-AMI
- Keywords
- ST Elevation Myocardial Infarction, Chest Pain, Smartwatch, Wearables, Electrocardiography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario Santa LuciaUniversity, hospital or other
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 24 Aug 2026 (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.
The main symptom that initiates the diagnostic and therapeutic process for patients with suspected acute coronary syndrome is chest pain. Based on a standard 12-lead electrocardiogram (ECG), patients can be diagnosed with ST-segment elevation myocardial infarction (STEMI), which requires immediate medical treatment. Recently, wearable devices like smartwatches with ECG capabilities have opened new pathways for cardiac triage, but their diagnostic precision and technical viability in a real, unselected Emergency Department setting need to be confirmed.
The primary objective of this prospective, observational study is to compare the diagnostic capacity of a 9-lead ECG obtained with a smartwatch against the standard 12-lead ECG for diagnosing STEMI in patients consulting for chest pain.
During the study, patients evaluated by the on-call cardiologist for ischemic chest pain will undergo their standard care. In addition to the standard 12-lead ECG, a 9-lead ECG will be sequentially recorded using a smartwatch. This is an observational study, meaning the smartwatch recording will not cause any delay in clinical action or negatively impact the patient's standard treatment.
Specifically, the study aims to:
- Analyze the diagnostic agreement between expert cardiologists when blindly and independently classifying the smartwatch recordings versus the standard ECG recordings as "STEMI" or "non-STEMI".
- Evaluate the technical feasibility of using the smartwatch in an Emergency Department setting by assessing the percentage of unreadable records due to artifacts.
Detailed description
Background and Rationale:
The clinical spectrum of acute coronary syndrome (ACS) is broad, with chest pain being the primary symptom initiating the diagnostic and therapeutic cascade. In patients with ST-segment elevation myocardial infarction (STEMI), immediate reperfusion -primarily via percutaneous coronary intervention (PCI)-is crucial. While primary PCI has significantly reduced mortality, minimizing systemic delays remains vital.
Recently, wearable devices with electrocardiographic (ECG) capabilities have emerged as potential tools for ultra-early cardiac triage. Previous research, such as the SMARTAMI study, demonstrated that a sequential 9-lead smartwatch ECG has high sensitivity and specificity for detecting STEMI. However, these prior studies often compared confirmed myocardial infarction cases with healthy, asymptomatic cohorts in highly controlled environments. There is a critical need to validate the technical feasibility, signal quality, and diagnostic accuracy of this technology in a real-world Emergency Department (ED) setting with unselected patients, where factors like diaphoresis, acute pain, and time urgency complicate the recording process.
Study Design and Clinical Procedures:
This is a prospective, observational diagnostic validation and concordance study conducted in a real-world clinical setting. Patients evaluated by the on-call cardiologist for ischemic-profile chest pain will be consecutively enrolled. The study is purely observational; obtaining the smartwatch ECG will not delay standard clinical care, and standard medical management will remain unaltered.
Following standard protocols, an analog sequential 9-lead ECG (I, II, III, V1-V6) will be recorded using a smartwatch alongside the standard 12-lead ECG.
Blinding and Data Evaluation:
A rigorous double-blind, independent analysis will be performed. The on-call cardiologists responsible for acquiring the tracings in the ED will not participate in their interpretation. Both the standard 12-lead ECGs and the smartwatch ECGs will be completely anonymized using unique alphanumeric codes. Subsequently, independent expert cardiologists will blindly evaluate the tracings, classifying them as "STEMI" or "non-STEMI" without any knowledge of the patient's clinical data or the origin of each specific recording.
Statistical Approach and Sample Size:
Based on prior literature in controlled settings reporting a 93% sensitivity, this real-world study conservatively estimates an 85% expected sensitivity due to ED-specific variables (e.g., signal noise, diaphoresis). To achieve a 10% margin of error with a 95% confidence level, a sample size of 49 confirmed STEMI positive cases is required. Consecutive recruitment will continue uninterrupted until this target is reached. Patients enrolled during this period who are ultimately diagnosed as "non-STEMI" will be retained in the database to calculate the specificity of the device.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| General cohort | – | Diagnostic Test: ECG smartwatch recording |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of unselected patients presenting to the Emergency Department at Hospital Universitario Santa Lucía (Cartagena) who are evaluated by the on-call cardiologist for ischemic-profile chest pain. This represents a real-world clinical cohort in an acute setting. Patients with extreme hemodynamic instability (where an additional recording would delay critical emergency treatment) and those with baseline electrocardiogram alterations (such as prior left bundle branch block or pacemaker-mediated pacing) that preclude proper ST-segment interpretation are excluded from this population.
Key inclusion criteria (1 listed)
- Patients evaluated by the on-call cardiologist for chest pain with an ischemic profile.
Key exclusion criteria (3 listed)
- Patients with extreme hemodynamic instability where the additional recording would cause an ethically unacceptable delay in their treatment.
- Patients with a prior diagnosis of left bundle branch block or pacemaker-mediated pacing.
- Patients who decline participation in the registry.
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 |
|---|---|---|
| ECG smartwatch recordingRecording a 9-lead ECG with a smartwatch | Diagnostic test | General cohort |
Primary outcome
Smartwatch ECG records' ability to diagnose STEMI
Time frame: From enrollment to the blinded analysis at the end of the recruitment
Analyze the diagnostic agreement between expert cardiologists when blindly and independently classifying the smartwatch recordings versus the standard ECG recordings as "STEMI" or "non-STEMI".
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Background: PubMed 32865545Spaccarotella CAM, Polimeni A, Migliarino S, Principe E, Curcio A, Mongiardo A, Sorrentino S, De Rosa S, Indolfi C. Multichannel Electrocardiograms Obtained by a Smartwatch for the Diagnosis of ST-Segment Changes. JAMA Cardiol. 2020 Oct 1;5(10):1176-1180. doi: 10.1001/jamacardio.2020.3994.
- 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.
Hospital General Universitario Santa Lucia
Cartagena, Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of STEMI - ST-segment Elevation Myocardial Infarction and Chest Pain, run by Hospital General Universitario Santa Lucia at 1 site in Spain.
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 3 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: looking for participants now, as of the sponsor's last update on 26 Aug 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartwatch ECG records' ability to diagnose STEMI (time frame: From enrollment to the blinded analysis at the end of the recruitment). 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 NCT07780942, 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 26 Aug 2026.