UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000052465 |
|---|---|
| Receipt number | R000059828 |
| Scientific Title | CREDO-Kyoto Registry Cohort-3 QFR Study |
| Date of disclosure of the study information | 2023/10/11 |
| Last modified on | 2023/10/11 15:47:13 |
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Basic information
Public title
CREDO-Kyoto Registry Cohort-3 QFR Study
Acronym
CREDO-Kyoto Registry Cohort-3 QFR Study
Scientific Title
CREDO-Kyoto Registry Cohort-3 QFR Study
Scientific Title:Acronym
CREDO-Kyoto Registry Cohort-3 QFR Study
Region
| Japan |
Condition
Condition
Coronary artery disease/multi-vessel disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the comprehensive significance of functional ischemia assessment and its usefulness in determining the optimal treatment approach, by performing three-dimensional quantitative analysis of preoperative coronary angiography images and non-invasively calculating the Quantitative Flow Ratio (QFR) for patients with three-vessel coronary artery disease who have undergone initial coronary revascularization.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
death, myocardial infarction or stroke
Key secondary outcomes
all-cause death, cardiovascular death, noncardiovascular death, myocardial infarction, stent thrombosis, stroke, major bleeding, and revascularization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with three-vessel coronary artery disease who have undergone initial coronary revascularization.
Key exclusion criteria
Cases where preoperative coronary angiographic images are difficult to obtain.
Cases where the image quality of coronary angiography is unsuitable for QFR analysis.
Target sample size
2525
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Shiomi |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8397
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
075-751-4255
hishiomi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Tamura |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Cardiovascular Medicine
Zip code
606-8397
Address
54 Shogoin-kawahara-cho, Sakyo-ku, Kyoto City, Kyoto
TEL
075-751-4255
Homepage URL
tamura_1259@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2023 | Year | 10 | Month | 11 | 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
| 2023 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Association between QFR-based classification of three-vessel diseases (whether functional three-vessel disease or not) and the long-term clinical outcome.
Management information
Registered date
| 2023 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059828
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
