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ALIGN-ACS Pilot Study
Sponsor: HeartBeam, Inc.
Summary
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.
Official title: Prospective Multicenter Pilot Observational Study Evaluating the Diagnostic Performance of the HeartBeam 3-Lead ECG System in Detecting Acute Coronary Syndrome
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
120
Start Date
2026-03-05
Completion Date
2026-08
Last Updated
2026-07-20
Healthy Volunteers
No
Conditions
Interventions
ECG
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.
Locations (1)
University Clinical Centre of Serbia
Belgrade, Serbia