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Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score — FACC  

Observational Clinical Trial

Official title:
Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03548753
Study type Observational
Source Odense University Hospital
Contact
Status Completed
Phase
Start date September 2, 2016
Completion date April 2018
View Details
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