ALIGN-ACS Pilot Study

NCT07715474 | Active Not Recruiting FDA Device

• 1 other identifier: HB_ALIGN-ACS_Pilot
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ACS Detection, ambulatory ECG

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day - acute recording from ED

Other Outcomes (1)

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

  1 day - acute recording from ED

Study Arms (1)

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

Interventions

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.

Patients presenting to the ED with symptoms suggestive of ACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital ED

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• HeartBeam, Inc.: lead

Study Sites (1)

University Clinical Centre of Serbia

Belgrade, Serbia

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: March 5, 2026
• Primary Completion: June 30, 2026
• Study Completion: August 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)