UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040475 |
|---|---|
| Receipt number | 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 | 2021/04/02 05:53:45 |
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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
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
ta.brilliantsea@gmail.com
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046074
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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