Status:
COMPLETED
Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
Lead Sponsor:
Seoul National University Hospital
Collaborating Sponsors:
Keimyung University Dongsan Medical Center
Inje University Ilsan Paik Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
20+ years
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 a...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
332 Patients enrolled
Trial Details
Trial ID
NCT06153927
Start Date
May 26 2022
End Date
October 31 2023
Last Update
December 1 2023
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea