UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000003361
Receipt number R000004082
Scientific Title A study of association between pericardial fat assessed by cardiac CT and cardiac function
Date of disclosure of the study information 2010/03/21
Last modified on 2011/03/23 23:27:40

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Basic information

Public title

A study of association between pericardial fat assessed by cardiac CT and cardiac function

Acronym

Pericardial fat and cardiac function

Scientific Title

A study of association between pericardial fat assessed by cardiac CT and cardiac function

Scientific Title:Acronym

Pericardial fat and cardiac function

Region

Japan


Condition

Condition

Patients suspected of cardiac disease

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the function of pericardial fat on cardiac function (systolic function and diastolic function)

Basic objectives2

Others

Basic objectives -Others

Observational study to clarify pathophysiology

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Pericardial fat volume and parameters of cardiac function assessed by echocardiography

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients suspected of cardialc disease and underwent cardiac CT examination

Key exclusion criteria

severe valvular disease, end-stage renal desease, severe arrythmia, poor prognosis patients

Target sample size

300


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Seigo Sugiyama

Organization

Kumamoto University Facluty of life science

Division name

Cardiovascular medicine

Zip code


Address

1-1-1 Honjo, Kumamoto City 860-8556, Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Faculty of life science

Division name

Cardiovascular medicine

Zip code


Address


TEL

096-373-5175

Homepage URL


Email



Sponsor or person

Institute

Kumamoto University Faculty of life science, Department of cardiovascular medicine

Institute

Department

Personal name



Funding Source

Organization

Grant-in-aid for Scientific Research

Organization

Division

Category of Funding Organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2010 Year 03 Month 21 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

Completed

Date of protocol fixation

2010 Year 03 Month 21 Day

Date of IRB


Anticipated trial start date

2010 Year 03 Month 01 Day

Last follow-up date

2010 Year 10 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Tendency to associate between pericardial fat volume on CT and left ventricular diastolic dysfunction has been observed.


Management information

Registered date

2010 Year 03 Month 21 Day

Last modified on

2011 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004082


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name