UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013008 |
|---|---|
| Receipt number | R000015182 |
| Scientific Title | A prospective observational study of the mental disorder prevalence in patients with non-cardioembolic ischemic stroke - Effect of antiplatelet agents and serum lipid profile for mental function - |
| Date of disclosure of the study information | 2014/01/30 |
| Last modified on | 2014/01/29 16:13:19 |
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Basic information
Public title
A prospective observational study of the mental disorder prevalence in patients with non-cardioembolic ischemic stroke
- Effect of antiplatelet agents and serum lipid profile for mental function -
Acronym
A prospective observational study of the mental disorder prevalence in patients with non-cardioembolic ischemic stroke
- Effect of antiplatelet agents and serum lipid profile for mental function -
Scientific Title
A prospective observational study of the mental disorder prevalence in patients with non-cardioembolic ischemic stroke
- Effect of antiplatelet agents and serum lipid profile for mental function -
Scientific Title:Acronym
A prospective observational study of the mental disorder prevalence in patients with non-cardioembolic ischemic stroke
- Effect of antiplatelet agents and serum lipid profile for mental function -
Region
| Japan |
Condition
Condition
Non-cardioembolic ischemic stroke patients who started treatment within 7 days after the onset
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the prevalence of mental disorder in patients with non-cardio-
embolic ischemic stroke.
To decide the correlation among mental disorder, serum lipid profile and antiplatelet agents with non-cardioembolic ischemic stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Prevalence of patients with mental disorder by SDS, MMSE, and apathy scale at 12 months.
Key secondary outcomes
1) Correlation of mental disorder and serum lipid profile.
2) Correlation of mental disorder and antiplatelet agents.
3) Correlation of mental disorder and other observations.
4) modified Rankin Score at 12 months.
5) Incidence of stroke and TIA at 12 months.
6) Incidence of all vascular events at 12 months (Stroke, MI, PAD, etc).
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
1) Patients who were aged 20 years or more.
2) Patients who walk independently before stroke onset (modified Rankin Scale 0-2).
3) Patient who were given their informed consent and agreed to participate with willingness.
Key exclusion criteria
1) Patients who were diagnosed with cardioembolic infarction.
2) Patients suffered known malignancy.
3) Patients who have history of depression treatment.
4) Patients whom the principal investigator regarded as unsuitable for this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Nakashima |
Organization
Tottori University Hospital
Division name
Division of Neurology
Zip code
Address
36-1, Nishi-cho, Yonago 683-8504, Japan
TEL
0859-38-6757
kenaka@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hisanori Kowa |
Organization
Tottori University Hospital
Division name
Division of Neurology
Zip code
Address
36-1, Nishi-cho, Yonago 683-8504, Japan
TEL
0859-38-6757
Homepage URL
norkowa@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Neurology, Tottori University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
鳥取大学医学部附属病院（鳥取県）/ Tottori University Hospital (Tottori)
鳥取県立中央病院（鳥取県，参加予定）/ Tottori Prefecture Chuo Hospital (Tottori, preparing)
鳥取赤十字病院（鳥取県）/ Japanese Red Cross Tottori Hospital (Tottori)
鳥取県立厚生病院（鳥取県）/ Tottori Prefectural Kousei Hospital (Tottori)
山陰労災病院（鳥取県）/ Sanin Rosai Hospital (Tottori)
松江赤十字病院（島根県）/ Matsue Red Cross Hospital (Shimane)
松江市立病院（島根県）/ Matsue City Hospital (Shimane)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
continued
Management information
Registered date
| 2014 | Year | 01 | Month | 29 | Day |
Last modified on
| 2014 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015182
