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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037515 |
Receipt No. | 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 | 2020/07/30 |
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 |
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Condition | ||
Condition | Coronary artery disease | |
Classification by specialty |
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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 | |
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Interventions/Control_6 | |
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Interventions/Control_8 | |
Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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Target sample size | 400 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Juntendo University Graduate School of Medicine |
Institute | |
Department |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Perform observational research on events that occur one year after FFRCT analysis |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042422 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |