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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040475
Receipt No. R000046074
Scientific Title Determination of the appropriate procedure of revascularization In the multidisciplinary heart team discussion based on Quantitative Flow Ratio
Date of disclosure of the study information 2020/07/01
Last modified on 2020/07/01

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Basic information
Public title Determination of the appropriate procedure of revascularization In the multidisciplinary heart team discussion based on Quantitative Flow Ratio
Acronym DECISION QFR
Scientific Title Determination of the appropriate procedure of revascularization In the multidisciplinary heart team discussion based on Quantitative Flow Ratio
Scientific Title:Acronym DECISION QFR
Region
Japan

Condition
Condition Coronary artery disease/multi-vessel disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the feasibility of the functional SYNTAX score derived from quantitative flow ratio (QFR) in the heart team discussion, which is a minimal invasive and economical risk assessment score requiring less procedure time in patients with multi-vessel disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The agreement of the treatment decision (CABG-only or PCI-only/equipoise) between QFR-based discussion and FFR-based discussion (Cohen's Kappa)
Key secondary outcomes The agreement of the treatment decision of QFR-based discussion between before and after unblinding of the functional SYNATX score derived from FFR (Cohen's Kappa)
The agreement of the treatment decision (CABG-only or PCI-only/equipoise ) between QFR-based discussion and FFR-based discussion after unblinding (Cohen's Kappa)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Functional SYNTAX score derived from QFR
Interventions/Control_2 Functional SYNTAX score derived from FFR
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a) patients with stable angina who are candidate for the revascularization with PCI or CABG
b) patients with multi-vessel disease (=>2 vessels) including left anterior descending artery (AHA classification #6 and/or #7)
c) patients in which the respecified projection protocol for QFR analysis is available
Key exclusion criteria a) patients with a stenosis in left main coronary artery or ostial right coronary artery (=<3mm)
b) post-CABG patients
c) patients with chronic kidney disease or hemodialysis
d) patients with anatomical condition inappropriate for QFR analysis
e) patients with medicine provoking hyperaemia (adenosine)
f) patients who can not consent with a written document
Target sample size 260

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Matsuo
Organization Gifu heart center
Division name Cardiology
Zip code 500-8384
Address 4-14-4, Yabuta-Minami, Gifu city, Gifu, Japan
TEL 058-277-2277
Email matsuo@heart-center.or.jp

Public contact
Name of contact person
1st name Taku
Middle name
Last name Asano
Organization St. Luke's International Hospital
Division name Cardiology
Zip code 154-8560
Address 9-1, Akashi-cho, Chuou-ku, Tokyo, Japan
TEL 03-3541-5151
Homepage URL
Email ta.brilliantsea@gmail.com

Sponsor
Institute Gifu Heart Center
Institute
Department

Funding Source
Organization Japanese Society for The Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Gifu heart centre
Address 4-14-4, Yabuta-Minami, Gifu city, Gifu, Japan
Tel 058-277-2277
Email research-gifu@heart-center.or.jp

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
2020 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 21 Day
Last modified on
2020 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046074

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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