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Recruitment status
Unique ID issued by UMIN C000000217
Receipt No. 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

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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
Email

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
Email jason-office@umin.ac.jp

Sponsor
Institute National Cardiovascular Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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