UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043533 |
|---|---|
| Receipt number | R000049713 |
| Scientific Title | High-intensity signal on T1-weighted magnetic resonance imaging as a novel marker of intracoronary thrombus and intraplaque hemorrhage study |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/06/22 21:01:18 |
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Basic information
Public title
High-intensity signal on T1-weighted magnetic resonance imaging as a novel marker of intracoronary thrombus and intraplaque hemorrhage study
Acronym
HISTOIRE study
Scientific Title
High-intensity signal on T1-weighted magnetic resonance imaging as a novel marker of intracoronary thrombus and intraplaque hemorrhage study
Scientific Title:Acronym
HISTOIRE study
Region
| Japan |
Condition
Condition
Stable ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between clinical factors including biomarkers and high-intensity signals (HIS) on T1-weighted magnetic resonance imaging suggesting intracoronary thrombus and intraplaque hemorrhage in order to elucidate the mechanism for acute coronary syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between biomarkers and the distribution of HIS
Key secondary outcomes
Clinical predictors for the change of HIS in non-target lesions during follow-up period; the association between the plaque characteristics on coronary computed tomography and the presence of HIS; the prognostic impact of the distribution of HIS at baseline.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with stable ischemic heart disease diagnosed by tests including coronary computed tomography angiography undergoing elective percutaneous coronary intervention (PCI)
Key exclusion criteria
1. Patients with acute coronary
syndrome
2. Patients with prior PCI or coronary artery bypass grafting
3. Patients contraindicated to MR imaging
3a. Patients with claustrophobia
3b. Patients with pacemaker or implantable cardioverter defibrillator
3c. Patients judged as inappropriate for MR imaging by a treating physician
4. Patients who do not wish to participate in this clinical test
5. Patients judged as inappropriate by a treating physician
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3801
yoshiyama@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Yoshiyama |
Organization
Osaka city university graduate school of medicine
Division name
Department of cardiovascular medicine
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3801
Homepage URL
yoshiyama@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of cardiovascular medicine, Osaka city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Osaka City University Graduate School of Medicine
Address
6F, Abeno Medix, 1-2-7 Asahi-machi, Abeno-ku, Osaka 545-8585, Japan
Tel
06-6645-3456
ethics@med.osaka-cu.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
大阪市立大学医学部附属病院(大阪府)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | 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
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
Terminated
Date of protocol fixation
| 2021 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing particular.
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2022 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049713
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
