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Completed

NCT Number: NCT06153927

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CT-FFR

Diagnostic Test

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

Primary outcomes

  1. Diagnostic accuracy of CT-FFR

    Time frame: At the time of test

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

Secondary outcomes

  1. Spearman's correlation coefficient of CT-FFR with FFR

    Time frame: At the time of test

    Spearman's correlation coefficient of CT-FFR with FFR

  2. Agreement between CT-FFR and FFR

    Time frame: 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

    Time frame: 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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2023
Registry last updated
Dec 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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