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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011021
Receipt No. 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

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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
Email 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
Email mmmyosuke@yahoo.co.jp

Sponsor
Institute Yokohama Sakae Kyosai Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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