Clinical trial NCT03546933: VitalScan MCG Rule-out Multi-centre Pivotal Study - US
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Acute Coronary Syndrome
Lead sponsor: Creavo Medical Technologies Ltd
Sponsor class: INDUSTRY
Collaborators: name: University of Cincinnati
First posted: 2018-06-06
Enrollment: 651
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients that present to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS) who are in normal sinus rhythm

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of MCG
timeFrame: up to 3 month follow-up
Secondary outcomes:
measure: Proportion of adverse events and types
timeFrame: up to 3 month follow-up
measure: All-cause mortatility (divided into CV and non-CV causes) proportion
timeFrame: through 1 week, 3 month follow-up
measure: 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
timeFrame: up to 3 months follow-up
measure: MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard (adjudicated ACS/non-ACS diagnoses))
timeFrame: through 1 week, 3 month follow-up
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Cincinnati
name: Gregory J Fermann, MD
role: PRINCIPAL_INVESTIGATOR
References: