UMIN ID: C000000217
Registered date:14/09/2005
Japanese Study of Neurocognitive Function after Valve Repair and Replacement
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Mitral Valve repair/replacement |
| Date of first enrollment | 2004/06/01 |
| Target sample size | 300 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | 1) The changes of the scores of the higher cognitive function test battery 2) Post-operative incidence rate of asymptomatic cerebral infarction |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 40years-old |
|---|---|
| Age maximum | 75years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude 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 |
Related Information
| Primary Sponsor | National Cardiovascular Center |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 06-6833-5012 |
| jason-office@umin.ac.jp | |
| Affiliation | National Cardiovascular Center JaSON office |
| scientific contact | |
| Name | Ko Bando |
| Address | 5-7-1, Fujishirodai, Suita City, Osaka. 565-8565 Japan Japan |
| Telephone | |
| Affiliation | National Cardiovascular Center Dept. of Cardiovascular Surgery |