VitalScan MCG Rule-out Multi-centre Pivotal Study - US (MAGNET ACS)

Creavo Medical Technologies

Status: Terminated

Conditions: Acute Coronary Syndrome

Treatments: Device: VitalScan Magnetocardiograph

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03546933

CIP 003 (US)

Details and patient eligibility

About

A prospective multi-centre observational study to validate the diagnostic accuracy of a transportable magnetocardiograph device for acute coronary syndrome (ACS), focusing on rule-out capability, in patients who present to the emergency department with chest pain symptoms consistent with ACS.

Enrollment: 651 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
• 18+ year old male or female
• Patient is willing and able to give written informed consent

Exclusion criteria

• ST-segment Elevation MI (STEMI)
• Clear non-ischemic cause for symptoms (e.g. trauma)
• Hemodynamic instability on admission (e.g. BP>220mmHg systolic & >110mmHg diastolic, <80mmHg systolic & <40mmHg diastolic, HR>160bpm)
• Ventricular tachycardia or fibrillation that cannot be treated effectively
• Atrial fibrillation
• Thoracic metal implants
• Pacemaker or internal defibrillator
• Pregnancy (if after 20-week period)* or lactation
• Patient unable to lie down (i.e. supine position) or stay still on the examination bed
• Patient unable to understand the informed consent process and/or has a poor understanding of English (e.g. English- speaking relative/translator not available)
• Patient unable to comply with the requirements of the protocol

Trial design

651 participants in 1 patient group

Chest pain patients presenting to the ED

Description:

All patients that present to the emergency department with chest pain and potentially other symptoms consistent with ACS and meet all eligibility criteria will undergo VitalScan Magnetocardiograph.

Treatment:

Device: VitalScan Magnetocardiograph