The goal of this observational study is to evaluate the diagnostic performance of the HeartBeam ECG System for detection of acute coronary syndrome. The study will enroll adults who come to the emergency department with chest pain or other symptoms suggestive of ACS. Participants will take the HeartBeam ECG recording within minutes of standard 12-lead ECG.
The primary objective of the ALIGN-ACS pilot study is to obtain preliminary estimates of the diagnostic performance (sensitivity and specificity) of the HeartBeam 3-lead ECG System for detecting ACS, relative to an adjudicated gold-standard diagnosis, with the standard 12-lead ECG as comparator.
Study Type
OBSERVATIONAL
Enrollment
120
HeartBeam 3-dimensional 3-lead ECG recording is obtained within 10 minutes of the standard 12-lead ECG in the ED, with optional paired recordings obtained if patient is admitted, at discharge and subsequent follow-ups. Recordings are for research purposes only and are not used for clinical management.
University Clinical Centre of Serbia
Belgrade, Serbia
Sensitivity and specificity of the HeartBeam ECG for detection of ACS
Sensitivity and specificity of the HeartBeam ECG System for detection of ACS, reported as point estimates with 95% confidence intervals, adjudicated against the gold-standard diagnosis.
Time frame: 1 day - acute recording from ED
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