UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039328
Receipt number R000044839
Scientific Title Multicenter observational study to investigate the relationship between Plaque rupture and Wall shear stress in patients with acute coronary syndrome
Date of disclosure of the study information 2020/02/01
Last modified on 2023/12/03 14:48:32

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Basic information

Public title

Multicenter observational study to investigate the relationship between Plaque rupture and Wall shear stress in patients with acute coronary syndrome

Acronym

Multicenter observational study to investigate the relationship between Plaque rupture and Wall shear stress in patients with acute coronary syndrome

Scientific Title

Multicenter observational study to investigate the relationship between Plaque rupture and Wall shear stress in patients with acute coronary syndrome

Scientific Title:Acronym

Multicenter observational study to investigate the relationship between Plaque rupture and Wall shear stress in patients with acute coronary syndrome

Region

Japan


Condition

Condition

Acute coronary syndrome

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To observe the ruptured plaques in detail and to investigate the relationship between wall shear stress and plaque rupture, in acute coronary syndrome patients who underwent pre-intervention optical coherence tomography

Basic objectives2

Others

Basic objectives -Others

To investigate the relationship between wall shear stress and thin-capped fibroatheroma which exists in culprit lesion of acute coronary syndrome

Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Wall shear stress of plaque rupture

Key secondary outcomes

The relationship between optical coherence tomography(OCT) findings and wall shear stress, wall shear stress of thin-capped fibroatheroma


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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

The acute coronary syndrome patients who observed the plaque rupture in pre-intervention optical coherence tomography

Key exclusion criteria

The patients who underwent stent implantation or coronary artery bypass grafting in past at culprit lesion of acute coronary syndrome, The patients who could not observe ruptured plaque in optical coherence tomography, because of unsuccessful red cell removing, The patients who underwent balloon dilation with 2mm or more size, before underwent optical coherence tomography

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Otake
Middle name
Last name Hiromasa

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

650-0017

Address

Kusunoki Town 7-5-2, Chuuou-Ku, Kobe City, Japan

TEL

078-382-5111

Email

hotake@med.kobe-u.ac.jp


Public contact

Name of contact person

1st name Fukuyama
Middle name
Last name Yusuke

Organization

Kobe University Graduate School of Medicine

Division name

Division of Cardiovascular Medicine

Zip code

650-0017

Address

Kusunoki Town 7-5-2, Chuuou-Ku, Kobe City, Japan

TEL

078-382-5111

Homepage URL


Email

captainvega1987@yahoo.co.jp


Sponsor or person

Institute

Kobe University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

none

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

Kobe University Graduate School of Medicine

Address

Kusunoki Town 7-5-2, Chuuou-Ku, Kobe City, Japan

Tel

078-382-5111

Email

kansatsu@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

2020 Year 02 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

100

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

Completed

Date of protocol fixation

2019 Year 12 Month 01 Day

Date of IRB

2020 Year 01 Month 27 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2024 Year 03 Month 31 Day

Date trial data considered complete

2024 Year 03 Month 31 Day

Date analysis concluded

2024 Year 03 Month 31 Day


Other

Other related information

none


Management information

Registered date

2020 Year 01 Month 30 Day

Last modified on

2023 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044839


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name