ALIGN-ACS Pilot Study (ALIGN-ACS)

July 16, 2026 updated by: HeartBeam, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Serbia
      • Belgrade, Serbia
        • University Clinical Centre of Serbia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hospital ED

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients presenting to the ED with symptoms suggestive of ACS
Adults presenting to the emergency department with suspected acute coronary syndrome (ACS) are enrolled, and study recordings are obtained. HeartBeam ECG recordings are for research purposes only and will not be used for clinical decision-making. Participants undergo routine ED cardiac evaluation. Final ACS status for the study is determined independently by an adjudication team based on the totality of available clinical data.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day - acute recording from ED

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 day - acute recording from ED

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HeartBeam, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2026

Primary Completion (Actual)

June 30, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

July 13, 2026

First Submitted That Met QC Criteria

July 16, 2026

First Posted (Actual)

July 20, 2026

Study Record Updates

Last Update Posted (Actual)

July 20, 2026

Last Update Submitted That Met QC Criteria

July 16, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HB_ALIGN-ACS_Pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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