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Active, Not Recruiting

NCT Number: NCT07715474

ALIGN-ACS Pilot Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinical Centre of Serbia

Belgrade, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female subjects 18 years of age and older.
  • All-comers to the hospital ED with the symptoms of chest pain and an ECG taken on admission are considered for ACS evaluation.
  • Able and willing to sign ICF.

Exclusion criteria

  • Open chest wounds or recent (<30 days) surgery of the chest or abdomen.
  • Clinical conditions that, in the opinion of the Investigator, would compromise the patient's safety or ability to complete the protocol.

Treatment and study plan

ECG

Diagnostic Test

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.

Primary outcomes

  1. Sensitivity and specificity of the HeartBeam ECG for detection of ACS

    Time frame: 1 day - acute recording from ED

    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.

Other outcomes

  1. Descriptive comparison of diagnostic performance between HeartBeam 3-lead and 12-lead ECG

    Time frame: 1 day - acute recording from ED

    Descriptive comparison of sensitivity and specificity of the 3-lead versus the standard 12-lead ECG against the adjudicated gold standard, reported with 95% confidence intervals.

Sponsors and collaborators

Lead sponsor

HeartBeam, Inc.

Industry

Registry information

Official study title

Prospective Multicenter Pilot Observational Study Evaluating the Diagnostic Performance of the HeartBeam 3-Lead ECG System in Detecting Acute Coronary Syndrome

Acronym: ALIGN-ACS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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