Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153927
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Brief Title:
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 10 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 080 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
The presence of ischemia was defined as FFR 080 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None