Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2

Not Applicable

• Conditions: consecutive patients who had suspected significant coronary artery disease by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA

• Registration Number: JPRN-UMIN000022443
• Lead Sponsor: Department of Cardiology, Kyoto University Graduate School of Medicine,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

We excluded patients with characteristics unsuitable for CCTA, including contraindication to beta blockers, nitrates, or adenosine, advanced bradycardia, severe tachyarrhythmia, severe hypotension, severe asthma, chronic obstructive pulmonary disease, congenital heart disease, previous artificial device implantation such as pacemaker or prosthetic valve, previous percutaneous coronary intervention (PCI) with coronary stents, previous coronary artery bypass grafting, serum creatinine level greater than 1.5 mg/dL with or without hemodialysis, allergy to iodine contrast, pregnant state, acute coronary syndrome requiring emergency coronary angiography, recent myocardial infarction within 30 days before CCTA or coronary angiography, life expectancy less than 2 years, and inability to adhere to the study procedures. However, there was no exclusion criteria for the quality of CCTA images influenced by various artifacts, such as coronary motion, opacification of coronary artery lumen by calcified plaque, and misregistration.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FFRCT value <=0.80 for suspecting hemodynamically significant CAD in FFRCT, and invasive FFR value <=0.80 as a reference standard for hemodynamically significant CAD.

Secondary Outcome Measures

Name	Time	Method
Comparison of diagnostic performance of FFRCT between REAL-FFRCT1 and 2