Ignite Creation Date:
2024-05-06 @ 1:28 AM
Last Modification Date:
2024-10-26 @ 11:04 AM
Study NCT ID:
NCT01810198
Status:
COMPLETED
Last Update Posted:
2017-03-22
First Post:
2013-02-22
Brief Title:
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization
Sponsor:
MDDX LLC
Organization:
MDDX LLC
Study Overview
Official Title:
Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization Relation to CardioVascular Outcomes Cost Effectiveness and Quality of Life
Status:
COMPLETED
Status Verified Date:
2017-03
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:
CONSERVE
Brief Summary:
To determine the effectiveness safety and cost efficiency associated with a CCTA-guided selective catheterization strategy for stable patients but without known CAD and an American Heart Association American College of Cardiology Class II indication for non-emergent invasive coronary angiography
Detailed Description:
A prospective randomized controlled multicenter trial to determine the clinical and cost effectiveness of a selective catheterization strategy versus a direct catheterization strategy for stable patients with suspected but without known CAD and clinical indication for non-emergent invasive coronary angiography Subjects in the selective catheterization arm will be followed for a primary endpoint of non-inferiority for rates of major adverse cardiac events MACE as compare to subjects in the direct catheterization strategy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None