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

Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2 - REAL-FFRCT2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022443

Enrollment

Registered

2016-06-01

Start date

2016-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: consecutive patients who had suspected significant CAD by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Comparison of diagnostic performance of FFRCT between REAL-FFRCT1 and 2	—

Countries

Japan

Contacts

Public ContactTetsuma Kawaji

Kyoto University Graduate School of Medicine, Department of Cardiology

kawaji@kuhp.kyoto-u.ac.jp075-751-4255

Outcome results