Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve

Study Overview
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Brief Summary
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The current study evaluated the diagnostic performance for myocardial ischemia of on-site automatic CCTA-derived FFR (CT-FFR) using a commercially available workstation as compared with invasive FFR as a reference. The diagnostic performance of CT-FFR was compared to that of CCTA diameter stenosis.

Detailed Description
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This is a retrospective, multicenter, comparative, investigator-initiated study to evaluate the diagnostic performance of CT-FFR from routinely acquired CCTA data using the software HeartMedi+ 1.0 (AI Medic, Korea) to detect hemodynamically significant CAD. Patients who underwent CCTA within 90 days before invasive coronary angiography and FFR measurement will be screened in each participating center. After that, invasive coronary angiography, FFR data, and CCTA data will be anonymized and transferred to the independent core laboratories and analyzed in a blind fashion. The presence of ischemia was defined as FFR ≤0.80. Anatomical obstructive stenosis was defined as diameter stenosis on CCTA ≥50%, and the diagnostic performance of CT-FFR and CCTA stenosis for ischemia was compared.

Official Title
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Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Diagnostic Test: CT-FFR


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults aged 20 years or older individuals who had undergone ≥ 64 multidetector row CCTA within 90 days before invasive coronary angiography and FFR measurement individuals who had not experienced any clinical events or significant clinical changes between the time of CCTA and invasive coronary angiography Exclusion Criteria: previous coronary intervention or coronary bypass surgery in the target vessel invasive coronary angiography under unstable conditions previous myocardial infarction at target vessel territory congenital heart disease moderate or severe valvular heart disease previous valvular heart surgery left ventricular ejection fraction ≤40% or left ventricular hypertrophy previous cardiac device implantation body mass index >35 kg/m2 poor FFR tracing quality no information on the position of the FFR pressure wire heart rate ≥100 beats/min during CCTA CCTA calcium score ≥1000 no nitroglycerin prior to CCTA CCTA slice thickness >1.0 mm significant artifacts in CCTA

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with CCTA and FFR assessment<br>Patients with CAD who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study. | Diagnostic Test: CT-FFR<br>* CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of CT-FFR | Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR | At the time of test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spearman's correlation coefficient of CT-FFR with FFR | Spearman's correlation coefficient of CT-FFR with FFR | At the time of test | 
| Agreement between CT-FFR and FFR | Bland-Altman analysis was used to demonstrate the agreement between CT-FFR and FFR. | At the time of test | 
| Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis | Diagnostic performance to predict hemodynamically significant CAD included diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value. A comparison of diagnostic performance was performed using McNemar's test or weight generalized score statistic as appropriate. | At the time of test | 
| Comparison of discriminant ability of CT-FFR to that of CCTA stenosis | Discriminant ability to predict hemodynamically significant CAD was assessed by the area under the receiver-operating characteristic curve (AUC). The AUCs were compared by Delong's test | At the time of test | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computed Tomography-based Fractional Flow Reserve, Coronary Computed Tomography Angiography, Fractional Flow Reserve, Coronary Artery Disease