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ALIGN-ACS Pilot Study

NCT07715474 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-07-20

No results posted yet for this study

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.

Conditions

  • Acute Coronary Syndromes

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • HeartBeam, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-05
Primary Completion
2026-06-30
Completion
2026-08-31
FDA Device
Yes

Countries

  • Serbia

Study Locations

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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 NCT07715474 on ClinicalTrials.gov