Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Diagnostic test: CT-FFR

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.

• Study Type: Observational
• Enrollment (Actual): 332

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

CAD patients who underwent CCTA, invasive coronary angiography, and FFR measurement will be included in this study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with CCTA and FFR assessment; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of CT-FFR	Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR	At the time of test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spearman's correlation coefficient of CT-FFR with FFR	Spearman's correlation coefficient of CT-FFR with FFR	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.	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.	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	At the time of test

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Severance Hospital; Keimyung University Dongsan Medical Center; Chosun University Hospital; Inje University Ilsan Paik Hospital
• Investigators: Principal Investigator: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: November 22, 2023
• First Submitted That Met QC Criteria: November 22, 2023
• First Posted (Estimated): December 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 22, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Fractional Flow Reserve; Coronary Computed Tomography Angiography; Computed Tomography-based Fractional Flow Reserve
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID Numbers: D-2207-023-1337

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No