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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022163
Receipt No. 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

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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
Email 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
Email mishida@clin.medic.mie-u.ac.jp

Sponsor
Institute Department of Radiology, Mie Univesity Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019323

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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