UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039328
Receipt No. 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 2020/01/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Kobe University Graduate School of Medicine
Institute
Department

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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2020 Year 01 Month 30 Day
Last modified on
2020 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.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


Contact us.