UMIN-CTR Clinical Trial

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	Open public recruiting
Date of protocol fixation	2020 Year 06 Month 02 Day
Date of IRB	2020 Year 06 Month 09 Day
Anticipated trial start date	2020 Year 08 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	2021 Year 04 Month 02 Day

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