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
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
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
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
