VitalScan MCG Rule-out Multi-centre Pivotal Study - US

Acute Coronary Syndrome Clinical Trial

— MAGNET ACS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03546933
• Other study ID #: CIP 003 (US)
• Status: Terminated
• Start date: July 17, 2018
• Est. completion date: August 6, 2019

Study information

• Verified date: September 2019
• Source: Creavo Medical Technologies Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 651
• Est. completion date: August 6, 2019
• Est. primary completion date: August 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Device:
• VitalScan Magnetocardiograph
A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.

Locations

Country	Name	City	State
United States	University of Cincinnati	Cincinnati	Ohio
United States	Baylor College of Medicine	Houston	Texas
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Wake Forest Baptist Medical Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Creavo Medical Technologies Ltd	University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of MCG	Sensitivity and specificity for diagnosing ACS, focusing on rule-out, in chest pain patients with normal sinus rhythm	up to 3 month follow-up
Secondary	Proportion of adverse events and types		up to 3 month follow-up
Secondary	All-cause mortatility (divided into CV and non-CV causes) proportion		through 1 week, 3 month follow-up
Secondary	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
Secondary	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