SMARTwatch for the Diagnosis of ST-segment Elevation Myocardial Infarction in Patients With Chest Pain

NCT07780942 | Recruiting

• 1 other identifier: I-AREA2_26-68_SMART-CART-AMI
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

STEMI - ST-segment Elevation Myocardial Infarction; Chest Pain

Keywords

ST Elevation Myocardial Infarction; Chest Pain; Smartwatch; Wearables; Electrocardiography

Outcome Measures

Primary Outcomes (1)

• 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".

  From enrollment to the blinded analysis at the end of the recruitment

Study Arms (1)

General cohort

Diagnostic Test: ECG smartwatch recording

Interventions

ECG smartwatch recording DIAGNOSTIC_TEST

Recording a 9-lead ECG with a smartwatch

General cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients evaluated by the on-call cardiologist for chest pain with an ischemic profile.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital General Universitario Santa Lucia: lead

Study Sites (1)

Hospital General Universitario Santa Lucia

Cartagena, Murcia, 30202, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 32865545 BACKGROUND

MeSH Terms

Conditions

Chest Pain; ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 24, 2026
• Study Start: August 14, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Locations

ES (1)