Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03548753
Status:
COMPLETED
Last Update Posted:
2018-06-15
First Post:
2018-05-22
Brief Title:
Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score
Status:
COMPLETED
Status Verified Date:
2018-06
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:
FACC
Brief Summary:
A prospective blinded multicenter study for evaluation of chest pain patients with severe coronary calcium Agatston score 399 The objective is to evaluate if an initial non-invasive strategy with coronary computed tomography angiography CCTA including functional flow reserve derived from CCTA FFR-CT is as effective as invasive coronary angiography ICA including functional flow reserve FFR for the detection and exclusion of obstructive coronary artery disease CAD Study hypothesis initial non-invasive anatomic and functional testing is non-inferior to an invasive anatomic and functional testing strategy
Detailed Description:
Prospective blinded multicenter study evaluating the diagnostic performance of coronary computed tomography angiography CCTA including functional flow reserve derived from CCTA FFR-CT for the detection and exclusion of significant obstructive coronary artery disease CAD The reference standard vil be invasive coronary angiography ICA including functional flow reserve FFR Patients referred for elective CCTA because of suspected stable CAD are considered If the initial routine non-enhanced CT scan shows an Agatston score 399 the patient is eligible for study inclusion Four sites in the region of Southern Denmark will participate Odense University Hospital Svendborg Hospital Vejle Hospital and Esbjerg Hospital A total of 278 patients will be included
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