UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022163 |
|---|---|
| Receipt number | R000019323 |
| Scientific Title | Diagnostic and prognostic implication of quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI in patients with ishcemic heart diseas: comparison with 15O-H2O PET. |
| Date of disclosure of the study information | 2016/05/02 |
| Last modified on | 2019/03/08 16:46:32 |
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Basic information
Public title
Diagnostic and prognostic implication of quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI in patients with ishcemic heart diseas: comparison with 15O-H2O PET.
Acronym
Diagnostic and prognostic implication of quantitative myocardial perfusion by 3T MRI and radio water PET in ishcemic heart diseas patients.
Scientific Title
Diagnostic and prognostic implication of quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI in patients with ishcemic heart diseas: comparison with 15O-H2O PET.
Scientific Title:Acronym
Diagnostic and prognostic implication of quantitative myocardial perfusion by 3T MRI and radio water PET in ishcemic heart diseas patients.
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop the method for quantitative analysis of 3T myocaardial perfusion by using 15O-H2O PET as a reference and to evaluate diagnostic and prognostic implication of quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI in patients with coronary artery disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of coronary artery disease by quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI
Key secondary outcomes
Stratification of prognosis in patients with coronary artery disease by quantitative assessment of myocardial blood flow using 3T myocardial perfusion MRI
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
An adult patient with known or suspected coronary artery disease who is planned coronary angiography and reffered to cardiac MRI examination with an agreement to be enrolled in this study after obtaining informed consent
Key exclusion criteria
1. Contraindication to MRI examination.
2. Claustrophobia
3. Contraindication for the use of Gadolinium-based contrast material
4. Contraindication for the use of adenosine
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Sakuma |
Organization
Mie University Graduate School of Medicine
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
sakuma@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Ishida |
Organization
Mie University Hospital
Division name
Department of Radiology
Zip code
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-5029
Homepage URL
mishida@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Department of Radiology, Mie Univesity Hospital
Institute
Department
Personal name
Funding Source
Organization
1. KAKENHI
2. Scholarship donation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
三重大学医学部附属病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 02 | 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
Completed
Date of protocol fixation
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Using the cross-sectional method in which myocardial perfusion MRI will be compared to O15 water PET obtained in the same examination
Management information
Registered date
| 2016 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019323
| Research Plan | |
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| 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 |
