UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030428 |
|---|---|
| Receipt number | R000034743 |
| Scientific Title | The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery |
| Date of disclosure of the study information | 2017/12/16 |
| Last modified on | 2022/01/23 18:03:23 |
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Basic information
Public title
The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Acronym
The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery
Scientific Title
The evaluations of the incident rate of and risk factors for development of cognitive dysfunction in each surgical types of cardiovascular surgery
Scientific Title:Acronym
The development of and risk factor for postoperative cognitive dysfunction in cardiovascular surgery
Region
| Japan |
Condition
Condition
Patients for cardiovascular surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to evaluate the incident rate and risk factors for development of postoperative cognitive dysfunction(POCD) in each type of cardiovascular surgery.
Basic objectives2
Others
Basic objectives -Others
This is the observational study for development of postoperative cognitive dysfunction in cardiovascular surgeries.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POCD was defined as a 20% score or more reduction in at least two of the neuropsychological test. The evaluation of incident rate of POCD will performed in each different types of cardiovascular surgery
Key secondary outcomes
The association between the development of POCD and patients' background, humoral factors(blood concentration of symmetric dimethylarginine arginine,arginine,eicosapentaenoic acid,docosahexaenoic acid and arachidonic acid),intraoperative monitoring and factors, and postoperative factors will be evaluated.The daily life activity in 1 and 3 month postoperatively will be evaluated by questionnaire.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases of aortic valve replacement, transcatheter aortic valve implantation, mitral valve replacement or plasty, surgery for major aorta (open surgery, stent graft implantation) and off -pump CABG.
Key exclusion criteria
Cases with neurological disease, symptomatic cerebral infarction,impossible for performing neuropsychological test, acute phase of infective endocarditis, emergency case and without the evaluation of chest CT and brain MRI.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Ishida |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2291
ishid002@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Ishida |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
TEL
0836-22-2291
Homepage URL
ishid002@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB center Yamaguchi University Graduate School of Medicine
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan
Tel
0836-22-2428
me223@yamaguchi-u.ac.jp
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
| 2017 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jsa-shoroku.jp/search/detail_program/id:2621
Number of participants that the trial has enrolled
300
Results
In 103 patients with aortic valve replacement, arteriosclerotic of ascending and descending aorta and carotid were risk factors for postoperative cognitive dysfunction (POCD).In 29 cases with aortic aneurysm surgery and 34 cases of other cardiac surgery, no association of blood concentration of ADMA, arginine, EPA and arachidonic acid with POCD were observed in these cases. In 91 cases of mitral valve surgery, mitral valve calcification was one of the risk factors for development of POCD.
Results date posted
| 2019 | Year | 06 | Month | 16 | Day |
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
| 2017 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study for evaluating the development of postoperative cognitive dysfunction (POCD) in cardiovascular surgery cases who admit to the Yamaguchi university hospital. POCD is evaluated 7-12 postoperatively and the associating factors of it including patients background, humoral factors, intraoperative factors, intraoperative monitoring values and postoperative factors will also be evaluated in each surgery. Daily life activity will also be evaluate 1 and 3month postoperatively by questionnaire.
Management information
Registered date
| 2017 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034743
