UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039140 |
|---|---|
| Receipt number | R000044641 |
| Scientific Title | Histopathological Characterization of High-Intensity Signals in Coronary Plaques on Noncontrast T1-Weighted Magnetic Resonance Imaging |
| Date of disclosure of the study information | 2020/01/13 |
| Last modified on | 2020/01/13 21:50:01 |
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Basic information
Public title
Histopathological Characterization of High-Intensity Signals in Coronary Plaques on Noncontrast T1-Weighted Magnetic Resonance Imaging
Acronym
HIP vs. non-HIP on histopathology
Scientific Title
Histopathological Characterization of High-Intensity Signals in Coronary Plaques on Noncontrast T1-Weighted Magnetic Resonance Imaging
Scientific Title:Acronym
HIP vs. non-HIP on histopathology
Region
| Japan |
Condition
Condition
ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In a previous study that investigated the presence of coronary high intensity plaque (HIP) detected by non-contrast T1-weighted imaging (T1WI), the signal intensity of coronary plaque-to-cardiac muscle ratio (PMR) >1.0 was associated with coronary events. This study aimed to investigate the histopathological characteristics of HIPs in the coronary artery.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological observations between HIP and non-HIP groups.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
All patients with significant coronary stenosis (>70%) in the vessels that were large enough to perform directional coronary atherectomy (DCA) on computed tomography angiography or coronary angiography were enrolled in the study.
Key exclusion criteria
(1)Acute myocardial infarction
(2)Cardiac shock
(3)Serum creatinine >2.0mg/dL
(4)Patients who cannot undergo MRI
(5)Patients expected to die within 1 year with malignant disease
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Sawada |
Organization
Himeji Cardiovascular Center
Division name
Cardiology
Zip code
6700981
Address
520 kou saijo Himeji Hyogo Japan
TEL
0792933131
kenzouzu@gmail.com
Public contact
Name of contact person
| 1st name | KENZO |
| Middle name | |
| Last name | UZU |
Organization
Himeji Cardiovascular center
Division name
Cardiology
Zip code
670-0981
Address
520 kou saijo Himeji Hyogo Japan
TEL
0792933131
Homepage URL
kenzouzu@gmail.com
Sponsor or person
Institute
Himeji Cardiovascular center
Institute
Department
Personal name
Funding Source
Organization
Non
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Surgical Pathology, Hyogo College of Medicine, Nishinomiya, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Himeji Cardiovascular center
Address
520 kou saijo Himeji Hyogo Japan
Tel
0792933131
kenzouzu@gmail.com
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 | 01 | Month | 13 | 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
52
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
| 2017 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 04 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
First, the lesion is evaluated by cardiac MRI, and the lesion is divided into two groups, HIP and non-HIP group. Within 30 days after cardiac MRI, the lesion is treated with catheterization using directional coronary athrectomy, and the plaques are collected. The collected plaques are fixed in formalin, and deliver to the Department of Pathology, Hyogo College of Medicine with anonymized. All plaques are pathologicaly evaluated without patient'data. The obtained pathological data is analyzed at the Himeji Cardiovascular Center.
Management information
Registered date
| 2020 | Year | 01 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044641
