SMARTwatch for the Diagnosis of ST-segment Elevation Myocardial Infarction in Patients With Chest Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital General Universitario Santa Lucia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients evaluated by the on-call cardiologist for chest pain with an ischemic profile.
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
ECG smartwatch recording
Diagnostic testRecording a 9-lead ECG with a smartwatch
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: General cohort1 intervention
Trial outcomes
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".
Time frame
From enrollment to the blinded analysis at the end of the recruitmentSponsors and contacts
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Source ClinicalTrials.gov