Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02921438
Status:
COMPLETED
Last Update Posted:
2019-04-03
First Post:
2016-09-29
Brief Title:
VitalScan MCG Rule-out Multi-centre Pivotal Study - UK
Sponsor:
Creavo Medical Technologies Ltd
Organization:
Creavo Medical Technologies Ltd
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAGNET-ACS
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 RO 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 RO 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 CADThis 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 RO ACS with improved safety ie 2 false negative rate in patients presenting to an emergency setting with chest pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None