UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome
Acronym	Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome
Scientific Title	Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome
Scientific Title:Acronym	Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome
Region	Japan

Condition
Condition	Acute coronary syndrome(ACS)
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to investigate the relationship between optical coherence tomography (OCT)-derived FFR values and clinical outcome.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Target vessel failure (cardiac death, target-vessel related myocardial infarction, and ischaemia-driven target vessel revascularization)
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	25 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	ACS patients who underwent post-intervention optical coherence tomography
Key exclusion criteria	Cases of in-stent restenosis, in-stent occlusion, graft disease, only left main trunk artery disease, without stent implantation, or without analyzable OCT images
Target sample size	550

Research contact person
Name of lead principal investigator	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825846
Email	hotake@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Hiromasa Middle name Last name Otake
Organization	Kobe University Graduate School of Medicine
Division name	Division of Cardiovascular Medicine
Zip code	6500017
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL	0783825846
Homepage URL
Email	hotake@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University
Institute
Department

Funding Source
Organization	Kobe University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kobe university hospital clinical and translational reserch center
Address	7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel	0783826669
Email	ccrspprt@med.kobe-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	2021 Year 06 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	364
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	No longer recruiting
Date of protocol fixation	2021 Year 04 Month 13 Day
Date of IRB	2021 Year 04 Month 13 Day
Anticipated trial start date	2021 Year 04 Month 13 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective multi centers registry

Management information
Registered date	2021 Year 04 Month 07 Day
Last modified on	2021 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049688