An observational study in Acute Coronary Syndromes, sponsored by HeartBeam, Inc.. Active, not recruiting at 1 site in Serbia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by HeartBeam, Inc. · Observational
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.
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 120 is below the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →HeartBeam, Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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Hospital ED
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 1 day - acute recording from ED
Descriptive comparison of diagnostic performance between HeartBeam 3-lead and 12-lead ECG
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.
Time frame: 1 day - acute recording from ED
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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HeartBeam, Inc.