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

NCT ID: NCT06153927

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

332 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-26

Study Completion Date

2023-10-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Keywords

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Computed Tomography-based Fractional Flow Reserve Coronary Computed Tomography Angiography Fractional Flow Reserve Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with CCTA and FFR assessment

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

CT-FFR

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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CT-FFR

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Keimyung University Dongsan Medical Center

OTHER

Sponsor Role collaborator

Inje University Ilsan Paik Hospital

OTHER

Sponsor Role collaborator

Chosun University Hospital

OTHER

Sponsor Role collaborator

Severance Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bon-Kwon Koo

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bon-Kwon Koo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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D-2207-023-1337

Identifier Type: -

Identifier Source: org_study_id