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

NCT03546933 | Terminated DMC

• 1 other identifier: CIP 003 (US)
• Study Type: observational
• Target: 651
• Locations: 1 country
• Sites: 5

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.

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

VitalScan Magnetocardiograph DEVICE

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

Chest pain patients presenting to the ED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patient presents to the ED with chest pain syndrome of suspected cardiac origin (i.e. symptoms consistent with ACS)
• + year old male or female
• Patient is willing and able to give written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Creavo Medical Technologies Ltd: lead
• University of Cincinnati: collaborator

Study Sites (5)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267-0769, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Gregory J Fermann, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: June 6, 2018
• Study Start: July 17, 2018
• Primary Completion: August 6, 2019
• Study Completion: August 6, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)