UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000049255
Receipt number R000056086
Scientific Title Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis
Date of disclosure of the study information 2022/10/18
Last modified on 2022/10/18 07:52:54

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Basic information

Public title

Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis

Acronym

Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis

Scientific Title

Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis

Scientific Title:Acronym

Cardiac MRI findings of heart failure with reduced ejection fraction: A meta-analysis

Region

Japan


Condition

Condition

heart failure with reduced ejection fraction

Classification by specialty

Cardiology Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Although the cardiac MRI finding of heart failure with reduced ejection fraction (HFrEF) has been reported in previous studies, these findings's prevalence and clinical relevance are unclear. This meta-analysis will clarify the prevalence and prognostic value of CMR findings for HFrEF patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Prevalence of abnormalities of CMR findings and impact on the prognosis in HFrEF patients.

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Heart failure with ejection fraction

Key exclusion criteria

N/A

Target sample size



Research contact person

Name of lead principal investigator

1st name Shingo
Middle name
Last name Kato

Organization

Yokohama City University

Division name

Department of Diagnostic Radiology

Zip code

236-0004

Address

3-9, Fukuura, Kanazawaku, Yokohama, Japan

TEL

07026335766

Email

shingo.m12226@gmail.com


Public contact

Name of contact person

1st name Shingo
Middle name
Last name Kato

Organization

Yokohama City University

Division name

Department of Diagnostic Radiology

Zip code

236-0004

Address

3-9, Fukuura, Kanazawaku, Yokohama, Japan

TEL

07026335766

Homepage URL


Email

shingo.m12226@gmail.com


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

None

Address

None

Tel

None

Email

None


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

2022 Year 10 Month 18 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

Open public recruiting

Date of protocol fixation

2022 Year 10 Month 18 Day

Date of IRB

2022 Year 10 Month 18 Day

Anticipated trial start date

2022 Year 10 Month 18 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This meta-analysis will extract the prevalence of abnormalities in CMR findings or myocardial strain in HFrEF patients. In addition, we will integrate the hazard ratio of these findings for predicting adverse events.


Management information

Registered date

2022 Year 10 Month 18 Day

Last modified on

2022 Year 10 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056086


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name