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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036517
Receipt No. R000041604
Scientific Title IMAGE-HF registry (Investigation of clinical utility of cardiac MAGnetic resonance for patients with Heart Failure)
Date of disclosure of the study information 2019/05/10
Last modified on 2019/04/15

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Basic information
Public title IMAGE-HF registry (Investigation of clinical utility of cardiac MAGnetic resonance for patients with Heart Failure)
Acronym IMAGE-HF registry (Investigation of clinical utility of cardiac MAGnetic resonance for patients with Heart Failure)
Scientific Title IMAGE-HF registry (Investigation of clinical utility of cardiac MAGnetic resonance for patients with Heart Failure)
Scientific Title:Acronym IMAGE-HF registry
Region
Japan

Condition
Condition Heart failure, non-ischemic cardiomyopathy
Classification by specialty
Medicine in general Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to construct a multi center registry to evaluate clinical utility of cardiac magnetic resonance imaging for patients with heart failure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The main analysis items are as follows; severity of myocardial fibrosis on LGE MRI; pattern of fibrosis; diffuse myocardial fibrosis on T1 mapping; left ventricular and right ventricular function. The relationship between these parameters and prognosis will be assessed.
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
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with non-ischemic cardiomyopathy scanned with cardiac magnetic resonance imaging.
The definition of non-ischemic cardiomyopathy is as follows;
1. Left ventricular ejection fraction<50%
2. No significant coronary artery disease on X-ray CAG or CT angiography
Key exclusion criteria Hypertrophic cardiomyopathy; Cardiac sarcoidosis; Cardiac Amyloidosis; Severe aortic stenosis; Severe aortic regurgitation; Severe Mitral stenosis; ARVC; non-compaction
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Shingo
Middle name
Last name Kato
Organization Kanagawa Cardiovascular and Respiratory Center
Division name Department of Cardiology
Zip code 236-0051
Address 6-16-1, Tomiokahigashi, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-701-9581
Email shingo.m12226@gmail.com

Public contact
Name of contact person
1st name Shingo
Middle name
Last name Kato
Organization Kanagawa Cardiovascular and Respiratory Center
Division name Department of Cardiology
Zip code 236-0051
Address 6-16-1, Tomiokahigashi, Kanazawa, Yokohama, Kanagawa, Japan
TEL 045-701-9581
Homepage URL
Email shingo.m12226@gmail.com

Sponsor
Institute Kanagawa Cardiovascular and Respiratory Center
Institute
Department

Funding Source
Organization Kanagawa Cardiovascular and Respiratory Center
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 Kanagawa Cardiovascular and Respiratory Center
Address 6-16-1, Tomiokahigashi, Kanazawa, Yokohama, Kanagawa, Japan
Tel 045-701-9581
Email shingo.m12226@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
2019 Year 05 Month 10 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 15 Day
Date of IRB
2019 Year 05 Month 28 Day
Anticipated trial start date
2019 Year 05 Month 28 Day
Last follow-up date
2034 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients' clinical information will be collected by EDC database.

Management information
Registered date
2019 Year 04 Month 15 Day
Last modified on
2019 Year 04 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041604

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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