UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011021 |
|---|---|
| Receipt number | R000012903 |
| Scientific Title | Examination of rennin and aldosterone and detection of prmary aldosteronism in acute stroke |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2017/01/11 15:07:26 |
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Basic information
Public title
Examination of rennin and aldosterone and detection of prmary aldosteronism in acute stroke
Acronym
Examination of rennin and aldosterone and detection of prmary aldosteronism in acute stroke
Scientific Title
Examination of rennin and aldosterone and detection of prmary aldosteronism in acute stroke
Scientific Title:Acronym
Examination of rennin and aldosterone and detection of prmary aldosteronism in acute stroke
Region
| Japan |
Condition
Condition
Stroke, Primary Aldosteronism
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Neurology |
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We intend for the patients in this study for a stroke acute phase and investigate the actual situation of primary aldosteronism that the renin aldosterone measurement by the blood tests.
Basic objectives2
Others
Basic objectives -Others
Observational study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Final diagnosis of primary aldosteronism.
Key secondary outcomes
Secondary hypertension except primary aldosteronism.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who were hospitalized for a stroke acute phase.
Key exclusion criteria
Nothing particular.
Target sample size
450
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yosuke Miyaji |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Neurology and Stroke Medicine
Zip code
Address
132 Katsura-cho, Sakae-Ku, Yokohama, Kanagawa, Japan
TEL
045-891-2171
mmmyosuke@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yosuke Miyaji |
Organization
Yokohama Sakae Kyosai Hospital
Division name
Department of Neurology and Stroke Medicine
Zip code
Address
132 Katsura-cho, Sakae-Ku, Yokohama, Kanagawa, Japan
TEL
045-891-2171
Homepage URL
mmmyosuke@yahoo.co.jp
Sponsor or person
Institute
Yokohama Sakae Kyosai 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
横浜栄共済病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-016-0701-5
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
Main results already published
Date of protocol fixation
| 2013 | Year | 03 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
PA was finally diagnosed in 4.0 % of acute stroke patients and in 4.9 % of stroke patients with a history of hypertension.
Management information
Registered date
| 2013 | Year | 06 | Month | 23 | Day |
Last modified on
| 2017 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012903
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
