NCT02921438

Brief Summary

The study is a prospective multi-centre observational study to evaluate a portable magnetocardiograph device for the rule-out of acute coronary syndrome (ACS) in patients who present to the emergency department with chest pain and other symptoms consistent with ACS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
756

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

April 3, 2019

Status Verified

December 1, 2018

Enrollment Period

1.9 years

First QC Date

September 29, 2016

Last Update Submit

April 1, 2019

Conditions

Acute Coronary Syndrome

Keywords

Cardiovascular DiseasesHeart DiseasesMyocardial IschemiaNSTE ACSNSTEMIUnstable Angina PectorisCoronary Artery Disease

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

    at discharge, 3 months follow-up

Secondary Outcomes (4)

  • Proportion of adverse events and types

    at discharge, 3 months follow-up

  • All-cause mortality (divided into CV and non-CV causes) proportion

    through 1 week and 3 months follow-up

  • 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

    at discharge, 3 months follow-up

  • MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose])

    through 1 week and 3 months

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 MagnetocardiographDEVICE

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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-ischaemic cause for symptoms (e.g. trauma)
  • Haemodynamic 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Southmead Hospital, North Bristol NHS Trust

Bristol, United Kingdom

Location

Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

St George's University Hospitals NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Northern General Hospital

Sheffield, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Acute Coronary SyndromeCardiovascular DiseasesHeart DiseasesMyocardial IschemiaNon-ST Elevated Myocardial InfarctionAngina, UnstableCoronary Artery Disease

Condition Hierarchy (Ancestors)

Vascular DiseasesMyocardial InfarctionInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Steve Goodacre, MB ChB MRCP DiplMC FCEM

    University of Sheffield; Sheffield, UK

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 29, 2016

First Posted

October 3, 2016

Study Start

February 6, 2017

Primary Completion

December 14, 2018

Study Completion

February 28, 2019

Last Updated

April 3, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)