Prospective Multicenter Pilot Observational Study Evaluating the Diagnostic Performance of the HeartBeam 3-Lead ECG System in Detecting Acute Coronary Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- HeartBeam, Inc.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Sensitivity and specificity of the HeartBeam ECG for detection of ACS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported