UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2
Title of the study (Brief title)	REAL-FFRCT2
Region	Japan

Condition
Condition	consecutive patients who had suspected significant coronary artery disease by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To validate the feasibility and diagnostic performance of FFRCT in consecutive patients who had suspected significant CAD by CCTA with Nitrate spray in real clinical practice and evaluate the impact of Nitrate comparing with the diagnostic performance of FFRCT in REAL-FFRCT1
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	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.
Key secondary outcomes	Comparison of diagnostic performance of FFRCT between REAL-FFRCT1 and 2

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	consecutive patients who had suspected significant CAD by CCTA and undergoing invasive coronary angiography within 60 days after acquisition of CCTA
Key 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.
Target sample size	50

Research contact person
Name of lead principal investigator	Takeshi Kimura
Organization	Kyoto University Graduate School of Medicine,
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL	075-751-4255
Email	taketaka@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Tetsuma Kawaji
Organization	Kyoto University Graduate School of Medicine,
Division name	Department of Cardiology
Address	54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto 606-8507 Japan
TEL	075-751-4255
Homepage URL
Email	kawaji@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Cardiology, Kyoto University Graduate School of Medicine,
Institute
Department

Funding Source
Organization	Department of Cardiology, Kyoto University Graduate School of Medicine,
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 01 Day
Anticipated trial start date	2016 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	The pre-defined endpoints of the current study were 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. Per-vessel correlation between FFRCT and invasive FFR was assessed by Spearman`s correlation coefficients, and Bland-Altman analysis. Diagnostic performance of FFRCT was assessed by the area under the receiver operator characteristics curve (AUC) of FFRCT (<=0.80) for detecting hemodynamically significant coronary stenosis (invasive FFR<=0.80) on per-vessel basis. In AUC analysis, we adopted FFRCT value rounded off to one decimal place. Diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were also evaluated.

Management information
Registered date	2016 Year 05 Month 25 Day
Last modified on	2017 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025368