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.
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 Type
OBSERVATIONAL
Enrollment
278
Odense University Hospital
Odense, Odense C, Denmark
Per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR)
The primary outcome measure is the per-patient diagnostic accuracy of functional flow reserve (FFR-CT) derived from standard coronary computed tomography angiography (CCTA) compared to invasive coronary angiography (ICA) including functional flow ratio (FFR), which is considered the gold standard in the detection or exclusion of obstructive coronary artery disease (CAD)
Time frame: Comparison of the noninvasive and invasive diagnostic modalities is performed at least 90 days after enrollment of each of the included patients
Invasive coronary angiography (ICA) including functional flow ratio (FFR) without obstructive coronary artery disease
Percentage of patients with invasive coronary angiography (ICA) including functional flow reserve (FFR) measurement without evidence of obstructive coronary artery disease
Time frame: 90 days after inclusion
Coronary revascularization procedures
Percentage of coronary revascularization procedures (PCI and CABG) in patients with reduced FFR-CT vs. patients with normal FFR-CT
Time frame: 90 day after inclusion
Other clinical endpoints
Percentage of patients with the composite endpoint of all-cause mortality or myocardial infarction or unstable angina hospitalization
Time frame: 90 days after inclusion
Major complications from diagnostic invasive diagnostic procedures
Percentage of patients with major complications following invasive coronary angiography (ICA) including fractional flow reserve (FFR) measurement
Time frame: Within 72 hours after invasive procedure
Per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value
Assessing per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value
Time frame: At least 90 days after patient inclusion
Per-vessel correlation of FFR-CT numerical value with the FFR numerical value in patients undergoing FFR
The per-vessel correlation of FFRCT numerical value with the FFR numerical value in patients undergoing FFR
Time frame: At least 90 days after patient inclusion
The diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score vs. patients with very high calcium score
Comparison of the diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score (Agatston score 400-999) vs patients with very high calcium score (Agatston score ≥ 999)
Time frame: At least 90 days after patient inclusion
Costs and resource use.
Estimating the total costs of potentially unnecessary invasive coronary angiographies with functional flow ratio measurements
Time frame: 90 days after inclusion
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