Acute Coronary Syndrome
Conditions
Brief summary
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.
Interventions
A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.
Sponsors
University of Cincinnati
Creavo Medical Technologies Ltd
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of MCG | up to 3 month follow-up | Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of adverse events and types | up to 3 month follow-up |
| All-cause mortatility (divided into CV and non-CV causes) proportion | through 1 week, 3 month follow-up |
| 3.Change in sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm, according to low, intermediate and high PTP groups | up to 3 months follow-up |
| MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses)) | through 1 week, 3 month follow-up |
Countries
United States
Outcome results
None listed