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
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
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
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
