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 2022/04/24 19:31:23

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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 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

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

No longer recruiting

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

2022 Year 04 Month 24 Day



Link to view the page

Value
https://center6.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