UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037515 |
|---|---|
| Receipt number | R000042422 |
| Scientific Title | DYNAMIC-FFRct study (DiscoverY of Novel Assessment Myocardical IsChemia by FFRct study) |
| Date of disclosure of the study information | 2019/07/29 |
| Last modified on | 2022/07/31 14:45:43 |
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Basic information
Public title
DYNAMIC-FFRct study (DiscoverY of Novel Assessment Myocardical IsChemia by FFRct study)
Acronym
DYNAMIC FFRct study
Scientific Title
DYNAMIC-FFRct study (DiscoverY of Novel Assessment Myocardical IsChemia by FFRct study)
Scientific Title:Acronym
DYNAMIC FFRct study
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prognosis of patients with coronary artery disease diagnosed properly using FFRCT under insurance indication in Japan
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
To assess the incidence of major coronary events (MACE) 1 year after diagnosis of patients undergoing FFRCT.
MACE is all cause of death, nonfatal myocardial infarction and emergency hospitalization of ACS
Key secondary outcomes
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
| 15 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with stable clinical symptoms diagnosed with CAD by CCTA and FFRCT indication under Japanese insurance indication.
Key exclusion criteria
1.Not CAD by CCTA
2.It was judged as unreadable due to severe artefacts.
3.Life expectancy less than 1 year
4.Inability to comply with follow-up period requirements
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Shinichiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Juntendo University Graduate School of Medicine
Division name
Cardiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
snfujimo@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Fujimoto |
Organization
Juntendo University Graduate School of Medicine
Division name
Cardiology
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
snfujimo@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo Clinical Research and Trial Center
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
kenkyu5858@juntendo.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
| 2019 | Year | 07 | Month | 29 | 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
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
Perform observational research on events that occur one year after FFRCT analysis
Management information
Registered date
| 2019 | Year | 07 | Month | 29 | Day |
Last modified on
| 2022 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042422
| 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 |
