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

Odense University Hospital

Status: Completed

Conditions: Observational

Study type: Observational

Funder types: Other

Identifiers

NCT03548753

HM19501968

Details and patient eligibility

About

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.

Full 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.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• An estimated likelihood for the presence of significant CAD between 15% and 85%
• Clinical stable patients with symptoms of suspected CAD referred for CTTA
• Initial routine non-enhanced CT scan shows an Agatston score >399
• Written informed consent
• Accept to undergo elective invasive coronary angiography (ICA) within 90 days

Exclusion criteria

• Known prior myocardial infarction
• Prior percutaneous coronary intervention (PCI)
• Prior coronary artery bypass surgery (CABG)
• Pacemaker or internal defibrillator lead implantation
• Prosthetic heart valve
• Atrial fibrillation
• Renal Insufficiency (<40 mL/min)
• Known anaphylactic reaction to iodinated contrast
• Pregnancy

Trial design

278 participants in 1 patient group

Patients with Agatston score > 399

Description:

1. Coronary computed tomography angiography with FFR-CT 2. Invasive coronary angiography with FFR