Clinical trial NCT03548753: Use of FFR-CT in Stable Intermediate Chest Pain Patients With Severe Coronary Calcium Score
Official title: Functional and Anatomical Testing in Intermediate Risk Chest Pain Patients With Severe Coronary Calcium Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Observational
Keywords: Angina
Chest pain
Diagnostic tests
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2018-06-07
Enrollment: 278
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical stable outpatients with symptoms of suspected coronary artery disease (CAD) referred for coronary computed tomography angiography (CCTA) as first-line noninvasive diagnostic test at one of the four participating centers are eligible for study inclusion, if the initial routine non-enhanced CT scan shows an Agatston score \> 399.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Comparison of the noninvasive and invasive diagnostic modalities is performed at least 90 days after enrollment of each of the included patients
Secondary outcomes:
measure: Invasive coronary angiography (ICA) including functional flow ratio (FFR) without obstructive coronary artery disease
timeFrame: 90 days after inclusion
measure: Coronary revascularization procedures
timeFrame: 90 day after inclusion
measure: Other clinical endpoints
timeFrame: 90 days after inclusion
measure: Major complications from diagnostic invasive diagnostic procedures
timeFrame: Within 72 hours after invasive procedure
measure: Per-patient and per-vessel diagnostic performance of FFR-CT by means of accuracy, sensitivity, specificity, positive predictive value, and negative predictive value
timeFrame: At least 90 days after patient inclusion
measure: Per-vessel correlation of FFR-CT numerical value with the FFR numerical value in patients undergoing FFR
timeFrame: At least 90 days after patient inclusion
measure: The diagnostic accuracy of FFR-CT in subgroups of patients with high calcium score vs. patients with very high calcium score
timeFrame: At least 90 days after patient inclusion
measure: Costs and resource use.
timeFrame: 90 days after inclusion
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Odense C
Study officials:
affiliation: Professor, MD, DMSc
name: Hans Mickley, MD
role: STUDY_CHAIR
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