UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Hajime Sakuma
Organization	Mie University Graduate School of Medicine
Division name	Department of Radiology
Address	2-174 Edobashi, Tsu, Mie
TEL	059-231-5029
Email	sakuma@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Masaki Ishida
Organization	Mie University Hospital
Division name	Department of Radiology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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