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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022443
Receipt No. R000025368
Scientific Title Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2
Date of disclosure of the study information 2016/06/01
Last modified on 2017/11/28

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Basic information
Public title Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2
Acronym REAL-FFRCT2
Scientific Title Real-world fEAsibiLlity of noninvasive Fractional Flow Reserve derived from coronary Computed Tomography angiography 2
Scientific Title:Acronym 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
1st name
Middle name
Last name Takeshi Kimura
Organization Kyoto University Graduate School of Medicine,
Division name Department of Cardiology
Zip code
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
1st name
Middle name
Last name Tetsuma Kawaji
Organization Kyoto University Graduate School of Medicine,
Division name Department of Cardiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 06 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025368

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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