Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05825911
Status:
RECRUITING
Last Update Posted:
2023-04-26
First Post:
2023-04-11
Brief Title:
Evaluation of Diagnostic Accuracy of MCGMagnetocardiography Scan in Suspected Coronary Artery Disease
Sponsor:
AMCG
Organization:
AMCG
Study Overview
Official Title:
Evaluation of Diagnostic Accuracy of MCG Scan in Suspected Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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:
EDAM-CAD
Brief Summary:
This multicenter clinical trial is designed to evaluate the diagnostic accuracy of MCG scan in detecting significant CAD compared to the reference standard CAG
Detailed Description:
This is multicenter prospective observational trial to evaluate the diagnostic accuracy of magnetocardiographyMCG scan in detecting significant coronary artery diseaseCAD compared to the reference standard coronary arteriographyCAG Chest pain patients scheduled for CAG will be offered to enroll in this clinical trial and provide informed consent to undergo with a reststress MCG scan prior to CAG This MCG scan with a new 96 channel superconducting quantum interference deviceSQUID system is radiation-free contactless and takes less than ten minutes to complete Multiple studies have shown that the diagnostic accuracy of stress MCG scan is quite high in identifying patients with symptomatic CAD Results will be interpreted and compared to the results of cardiac SPECT stress test if available and CAG Participants will be followed up to 30 days via phone call or chart review 30 day major adverse cardiac eventMACE will be recorded and correlated with initial MCG scan results
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