Clinical trial NCT06153927: Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
Official title: Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Computed Tomography-based Fractional Flow Reserve
Coronary Computed Tomography Angiography
Fractional Flow Reserve
Coronary Artery Disease
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Keimyung University Dongsan Medical Center
name: Inje University Ilsan Paik Hospital
name: Chosun University Hospital
name: Severance Hospital
First posted: 2023-12-01
Enrollment: 332
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of CT-FFR
timeFrame: At the time of test
Secondary outcomes:
measure: Spearman's correlation coefficient of CT-FFR with FFR
timeFrame: At the time of test
measure: Agreement between CT-FFR and FFR
timeFrame: At the time of test
measure: Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis
timeFrame: At the time of test
measure: Comparison of discriminant ability of CT-FFR to that of CCTA stenosis
timeFrame: At the time of test
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: