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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06153927
• Other study ID #: D-2207-023-1337
• Status: Completed
• Start date: May 26, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 332
• Est. completion date: October 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• CT-FFR
CT-FFR was calculated using HeartMedi+ 1.0 according to the manufacturer's instructions

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (5)

Lead Sponsor	Collaborator
Seoul National University Hospital	Chosun University Hospital, Inje University Ilsan Paik Hospital, Keimyung University Dongsan Medical Center, Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spearman's correlation coefficient of CT-FFR with FFR	Spearman's correlation coefficient of CT-FFR with FFR	At the time of test
Secondary	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
Secondary	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
Secondary	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