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

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

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 Overview

• Status: Terminated
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Device: VitalScan Magnetocardiograph

• Study Type: Observational
• Enrollment (Actual): 651

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Methodist Hospital
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0769
      • University of Cincinnati
  • Tennessee
    • Nashville, Tennessee, United States, 37235
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chest pain patients presenting to the ED; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Creavo Medical Technologies Ltd
• Collaborators: University of Cincinnati
• Investigators: Principal Investigator: Gregory J Fermann, MD, University of Cincinnati

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 17, 2018
• Primary Completion (ACTUAL): August 6, 2019
• Study Completion (ACTUAL): August 6, 2019

Study Registration Dates

• First Submitted: May 9, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (ACTUAL): June 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 18, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome
• Other Study ID Numbers: CIP 003 (US)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No