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

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT06153927
• Collaborator: Keimyung University Dongsan Medical Center (Other), Inje University Ilsan Paik Hospital (Other), Chosun University Hospital (Other), Severance Hospital (Other)
• Enrollment: 332
• Location: 1
• Actual Duration (Months): 17.2
• Patients Per Site Per Month: 19.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	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 Design

• Study Type: Observational
• Actual Enrollment: 332 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Diagnostic Performance of On-site Automatic Coronary Computed Tomography Angiography-derived Fractional Flow Reserve
• Actual Study Start Date: May 26, 2022
• Actual Primary Completion Date: Jul 30, 2023
• Actual Study Completion Date: Oct 31, 2023

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of CT-FFR [At the time of test]

   Diagnostic accuracy of CT-FFR to detect hemodynamically significant CAD evaluated with an invasive FFR

Secondary Outcome Measures

1. Spearman's correlation coefficient of CT-FFR with FFR [At the time of test]

   Spearman's correlation coefficient of CT-FFR with FFR

2. Agreement between CT-FFR and FFR [At the time of test]

   Bland-Altman analysis was used to demonstrate the agreement between CT-FFR and FFR.

3. Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis [At the time of test]

   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.

4. Comparison of discriminant ability of CT-FFR to that of CCTA stenosis [At the time of test]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Seoul National University Hospital
• Keimyung University Dongsan Medical Center
• Inje University Ilsan Paik Hospital
• Chosun University Hospital
• Severance Hospital

Investigators

• Principal Investigator: Bon-Kwon Koo, MD, PhD, Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bon-Kwon Koo, Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT06153927
• Other Study ID Numbers: D-2207-023-1337
• First Posted: Dec 1, 2023
• Last Update Posted: Dec 1, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bon-Kwon Koo, Professor, Seoul National University Hospital: Computed Tomography-based Fractional Flow Reserve; Coronary Computed Tomography Angiography; Fractional Flow Reserve; Coronary Artery Disease
• Additional relevant MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease

Study Results

No Results Posted as of Dec 1, 2023