UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043858
Receipt number R000049688
Scientific Title Relationship between Intracoronary Optical Coherence Tomography Derived Virtual Fractional Flow Reserve and cardiovascular outcome on Acute coronary syndrome
Date of disclosure of the study information 2021/06/01
Last modified on 2021/04/07 13:06:06

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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 or person

Institute

Kobe University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name