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

Terminated

• Conditions: Acute Coronary Syndrome

• Registration Number: NCT03546933
• Lead Sponsor: Creavo Medical Technologies Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-06-04
• Study First Posted: 2018-06-06
• Study Start: 2018-07-17
• Primary Completion: 2019-08-06
• Study Completion: 2019-08-06
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 651

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (5)

IU Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Wake Forest Baptist Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States