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

NCT07780942 · tracked via the Priya Life Science Spain tracker

Sponsor

Hospital General Universitario Santa Lucia

Phase

Observational

Started

2026-08-14

Last updated

2026-08-26

Condition(s) studied

STEMI - ST-segment Elevation Myocardial InfarctionChest Pain

Investigational drug(s) / intervention(s)

ECG smartwatch recording

ECG smartwatch recording: Recording a 9-lead ECG with a smartwatch

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patients evaluated by the on-call cardiologist for chest pain with an ischemic profile. Exclusion Criteria: * 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.

Primary outcome measure(s)

Smartwatch ECG records' ability to diagnose STEMI — 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".

Trial sites (1)

Facility	City	Region	Status
Hospital General Universitario Santa Lucia	Cartagena	Murcia	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07780942 on ClinicalTrials.gov ↗ ← All trials in Spain