Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04739267
Status:
COMPLETED
Last Update Posted:
2023-05-11
First Post:
2021-01-27
Brief Title:
Acute Coronary Syndrome CardioFlux TM Study ACCMED
Sponsor:
Genetesis Inc
Organization:
Genetesis Inc
Study Overview
Official Title:
The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study
Status:
COMPLETED
Status Verified Date:
2023-05
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:
MAGNETO
Brief Summary:
Approximately 165 million people suffer from coronary artery disease CAD and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath commonly suggestive of acute coronary syndrome ACS To clinically assess ACS risk in these patients there are typically 2-6 hours of emergency room evaluation followed by 6-42 hours of an observation period prior to discharge The clinical pathway includes 1 1-3 ECGs 2 serial troponins 1 and 3 hours vs 1 and 6 hours and 3 other pertinent diagnostic information including but not limited to echocardiography stress testing andor CT Angiography Patients who are evaluated have presented with a low risk for ACS and maintain negative diagnostic results can potentially be discharged within 6 hours However 20-40 of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing such as stress testing The purpose of ACCMED is to measure the efficacy of Magnetocardiography MCG as a diagnostic tool to rule-inrule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score 2 and to allow safe and timely disposition of the patient to an appropriate level of care
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None