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NCT07780942Recruiting

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

Observational and Prospective Diagnostic Validation Study of the SMARTwatch for ST-segment Elevation Myocardial Infarction in Health Area of Cartagena

Source: ClinicalTrials.gov · Last updated 26 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
19 Aug 2026
Start date
14 Aug 2026
Primary completion date
Feb 2027
Lead sponsor
Hospital General Universitario Santa Lucia
NCT number
NCT07780942

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 14 Aug 2026 to the primary completion date, Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients with a prior diagnosis of left bundle branch block or pacemaker-mediated pacing.

Other

  • Patients with extreme hemodynamic instability where the additional recording would cause an ethically unacceptable delay in their treatment.
  • Patients who decline participation in the registry.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital General Universitario Santa Lucia
Coordinator of this site? Confirm its status
CartagenaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.