UMIN-CTR Clinical Trial

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
Email	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
Email	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
Email	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	Enrolling by invitation
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 11 Month 30 Day
Date of closure to data entry
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	2019 Year 07 Month 29 Day
Last modified on	2020 Year 07 Month 30 Day

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

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