UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000217 |
|---|---|
| Receipt number | R000000273 |
| Scientific Title | Japanese Study of Neurocognitive Function after Valve Repair and Replacement |
| Date of disclosure of the study information | 2005/09/14 |
| Last modified on | 2005/09/13 17:24:55 |
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Basic information
Public title
Japanese Study of Neurocognitive Function after Valve Repair and Replacement
Acronym
Japanese Study of Neurocognitive Function after Valve Repair and Replacement(JaSON)
Scientific Title
Japanese Study of Neurocognitive Function after Valve Repair and Replacement
Scientific Title:Acronym
Japanese Study of Neurocognitive Function after Valve Repair and Replacement(JaSON)
Region
| Japan |
Condition
Condition
Mitral Valve repair/replacement
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the changes of higher cognitive function before and after mitral valve repair/replacement and to detect the incidence of asymptomatic cerebral ischemic (and hemorrhagic) lesions during the same time period.
Basic objectives2
Others
Basic objectives -Others
1) The changes of the scores of the higher cognitive function test battery
2) Post-operative incidence rate of asymptomatic cerebral infarction
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
1) The changes of the scores of the higher cognitive function test battery
2) Post-operative incidence rate of asymptomatic cerebral infarction
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who are expected to undergo mechanical mitral valve replacement or mitral valuvuloplasty.
2) Patients >= 40 and < 75 years of age.
3) Patients willing and able to give informed consent
Key exclusion criteria
1) history of symptomatic stroke
2) present active infectious endocarditis
3) prior or planned operation of aortic valve or tricuspid valve
4) history of myocardial infarction within the past 6 months
5) PTCA or CABG is planned, or done within past 6 months
6) History of or suspected malignant tumor
7) Females of known or suspected pregnancy
8) Patients with recurrent deep venous thrombosis, or with genetic tendency of hypercoagulability
9) Abnormal results of labolatory data (chemical,CBC) within past 1 month
10) Patients with any contraindication of brain MRI
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ko Bando |
Organization
National Cardiovascular Center
Division name
Dept. of Cardiovascular Surgery
Zip code
Address
5-7-1, Fujishirodai, Suita City, Osaka. 565-8565 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Cardiovascular Center
Division name
JaSON office
Zip code
Address
TEL
06-6833-5012
Homepage URL
jason-office@umin.ac.jp
Sponsor or person
Institute
National Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
| 2005 | Year | 09 | Month | 14 | 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
Date of protocol fixation
| 2004 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Follow-up period:2 years after cardiac surgery
The changes of the results of higher cognitive function tests and brain MRI will be mainly investigated.
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2005 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000273
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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