A Study to Validate the Diagnostic Accuracy of a Transportable Magnetocardiograph Device for Acute Coronary Syndrome
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
NCT ID: NCT03546933
Sponsor Protocol Number: CIP 003 (US)
About this study
The purpose of this study is 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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patient presents to the Emergency Department (ED) with chest pain syndrome of suspected cardiac origin (i.e., symptoms consistent with acute cororonary syndrome (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.
More information
Publications
Publications are currently not available