Coronary Artery Disease
Conditions
Keywords
Computed Tomography-based Fractional Flow Reserve, Coronary Computed Tomography Angiography, Fractional Flow Reserve, Coronary Artery Disease
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTCT-FFR
CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions
Sponsors
Keimyung University Dongsan Medical Center
Inje University Ilsan Paik Hospital
Chosun University Hospital
Severance Hospital
Seoul National University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of CT-FFR | At the time of test | Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Agreement between CT-FFR and FFR | At the time of test | Bland-Altman analysis was used to demonstrate the agreement between CT-FFR and FFR. |
| Spearman's correlation coefficient of CT-FFR with FFR | At the time of test | Spearman's correlation coefficient of CT-FFR with FFR |
| Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis | At the time of test | 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. |
| Comparison of discriminant ability of CT-FFR to that of CCTA stenosis | At the time of test | 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 |
Countries
South Korea
Outcome results
None listed