An observational study in Coronary Artery Disease, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2023-12-01.
Sponsored by Seoul National University Hospital · Observational
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.
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 332 is close to the median of 336 across 1,947 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.
Exclusion Criteria:
Patients with CAD who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.
Diagnostic Test: CT-FFR
CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions
Diagnostic accuracy of CT-FFR
Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR
Time frame: At the time of test
Spearman's correlation coefficient of CT-FFR with FFR
Spearman's correlation coefficient of CT-FFR with FFR
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At the time of test
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital