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

NCT06153927 | Completed

• 1 other identifier: D-2207-023-1337
• Study Type: observational
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Spearman's correlation coefficient of CT-FFR with FFR

  At the time of test

• Agreement between CT-FFR and FFR

  At the time of test

• Comparison of diagnostic performance of CT-FFR to that of CCTA stenosis

  At the time of test

• Comparison of discriminant ability of CT-FFR to that of CCTA stenosis

  At the time of test

Study Arms (1)

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

Interventions

CT-FFR DIAGNOSTIC_TEST

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

Patients with CCTA and FFR assessment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: May 26, 2022
• Primary Completion: July 30, 2023
• Study Completion: October 31, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

KR (1)