Clinical trial NCT02921438: VitalScan MCG Rule-out Multi-centre Pivotal Study - UK
Official title: A Prospective Multi-centre Observational Study to Evaluate the Diagnostic Accuracy of a Portable 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Cardiovascular Diseases
Heart Diseases
Myocardial Ischemia
NSTE ACS
NSTEMI
Unstable Angina Pectoris
Coronary Artery Disease
Lead sponsor: Creavo Medical Technologies Ltd
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 756
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: Few, if any, studies have evaluated the rule-out (R/O) of non-ST-segment elevation (NSTE) ACS which requires the sensitivity and negative predictive value (NPV) of the test to approach 100%. An alternative triage approach, utilizing a portable magnetocardiography (MCG) instrument in the emergency setting, may lead to a more accurate R/O for NSTEMI, UA, and clinically significant non-ACS coronary artery disease (CAD), in patients presenting to the ED with chest pain. MCG in the emergency setting is a new use of this non-invasive technique and may serve as an adjunctive aid that can improve cardiac triage for NSTE ACS and clinically significant CAD.This raises the research question of whether MCG may be useful for the early triage of patients with acute chest pain. In the study protocol, a clinical evaluation is defined that will assess the ability of a portable MCG instrument, using a fixed algorithm, to R/O ACS, with improved safety (i.e. \<\< 2% false negative rate) in patients presenting to an emergency setting with chest pain.

Eligibility criteria: 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-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

Primary outcomes:
measure: Sensitivity and specificity of MCG
timeFrame: at discharge, 3 months follow-up
Secondary outcomes:
measure: Proportion of adverse events and types
timeFrame: at discharge, 3 months follow-up
measure: All-cause mortality (divided into CV and non-CV causes) proportion
timeFrame: through 1 week and 3 months follow-up
measure: 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
timeFrame: at discharge, 3 months follow-up
measure: MACE post-presentation to the ED (rule-out of ACS divided into MCG vs reference standard [adjudicated ACS/non-ACS diagnose])
timeFrame: through 1 week and 3 months
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: Southmead Hospital, North Bristol NHS Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, Univeristy Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: St George's University Hospitals NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Queens Medical Centre, Nottingham Univeristy Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
Study officials:
affiliation: University of Sheffield; Sheffield, UK
name: Steve Goodacre, MB ChB MRCP DiplMC FCEM
role: PRINCIPAL_INVESTIGATOR
References: