ALIGN-ACS Pilot Study

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07715474

Acronym

ALIGN-ACS

Enrollment

120

Registered

2026-07-20

Start date

2026-03-05

Completion date

2026-08-01

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes

Keywords

ACS Detection, ambulatory ECG

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.

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.

Interventions

DIAGNOSTIC_TESTECG

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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity and specificity of the HeartBeam ECG for detection of ACS	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.

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 21, 2026