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

NCT07780942 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-08-26

No results posted yet for this 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.

Conditions

  • STEMI - ST-segment Elevation Myocardial Infarction
  • Chest Pain

Interventions

DIAGNOSTIC_TEST

ECG smartwatch recording

Recording a 9-lead ECG with a smartwatch

Sponsors & Collaborators

  • Hospital General Universitario Santa Lucia

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-14
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07780942 on ClinicalTrials.gov