UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003530 |
|---|---|
| Receipt number | R000004285 |
| Scientific Title | Endotherial dysfunction evaluated by Flow-Mediated Dilatation(FMD) and Reactive Hyperemia-Peripheral Arterial Tonometry( RH-PAT) in patients with ischemic stroke |
| Date of disclosure of the study information | 2010/04/24 |
| Last modified on | 2010/04/24 15:15:21 |
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Basic information
Public title
Endotherial dysfunction evaluated by Flow-Mediated Dilatation(FMD) and Reactive Hyperemia-Peripheral Arterial Tonometry( RH-PAT) in patients with ischemic stroke
Acronym
Endotherial dysfunction evaluated by Flow-Mediated Dilatation(FMD) and Reactive Hyperemia-Peripheral Arterial Tonometry( RH-PAT) in patients with ischemic stroke
Scientific Title
Endotherial dysfunction evaluated by Flow-Mediated Dilatation(FMD) and Reactive Hyperemia-Peripheral Arterial Tonometry( RH-PAT) in patients with ischemic stroke
Scientific Title:Acronym
Endotherial dysfunction evaluated by Flow-Mediated Dilatation(FMD) and Reactive Hyperemia-Peripheral Arterial Tonometry( RH-PAT) in patients with ischemic stroke
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess FMD and RH-PAT among stoke patients.In addition,We assess the relationships between clinical characteristics of stroke(Type of stroke,hyper lipidemia, Diabetes mellitus,blood coagulopathy,
hypertension,postprandial hyperglycemia on continuous glucose monitoring, therapy for stroke,etc)
and endotherial dysfunction evaluated by FMD and RH-PAT.
Basic objectives2
Others
Basic objectives -Others
To assess the clinical characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
endotherial dysfunction evaluated by FMD and RH-PAT among stoke patients
Key secondary outcomes
Several clinical characteristics of stroke which affect FMD and RH-PAT
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
Both outpatients with chronic-stage of ischemic stroke or TIA , and hospitalized patients with newly diagnosed ischemic stroke or TIA are enrolled. Matched outpatients and hospitalized patients without ischemic stroke or TIA episode are enrolled as disease controls. The patients are recruited from the Jikei University Daisan Hospital.
Key exclusion criteria
Exclusion criteria for controls is any ischemic lesions on MRI image and vascular stenosis on MRA image.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makiko Yogo |
Organization
Daisan Hospital,The Jikei University School of Medicine
Division name
Depertment of Neurology
Zip code
Address
4-11-1 Izumihoncho Komae Tokyo Japan
TEL
03-3480-1151(ext.3710)
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makiko Yogo |
Organization
Daisan Hospital,The Jikei University School of Medicine
Division name
Depertment of Neurology
Zip code
Address
4-11-1 Izumihoncho Komae Tokyo Japan
TEL
03-3480-1151(ext.3164)
Homepage URL
edoendo@gmail.com
Sponsor or person
Institute
Depertment of Neurolgy,
Daisan Hospital,The Jikei University School of Medicine
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
東京慈恵会医科大学附属第三病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 24 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
As a case control study, comparing with disease control group, we evaluate decrease of %FMD and PAT ratio in ischemic stroke patients group. And We assess clinical characteristics relating to these values retrospectively.
Management information
Registered date
| 2010 | Year | 04 | Month | 24 | Day |
Last modified on
| 2010 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004285
