UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036517 |
|---|---|
| Receipt number | 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 | 2025/10/10 15:15:35 |
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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
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
shingo.m12226@gmail.com
Sponsor or person
Institute
Kanagawa Cardiovascular and Respiratory Center
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
950
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
| 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
| 2025 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041604
