UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015195 |
|---|---|
| Receipt number | R000017661 |
| Scientific Title | Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study |
| Date of disclosure of the study information | 2014/09/17 |
| Last modified on | 2016/09/21 17:55:20 |
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Basic information
Public title
Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Acronym
Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Scientific Title
Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Scientific Title:Acronym
Clinical implication of initial blood pressure decrease on sit-to-stand orthostatic stress test: A prospective observational study
Region
| Japan |
Condition
Condition
Atherosclerotic disease
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Influence of initial blood pressure decrease on sit-to-stand orthostatic test for cardiovascular outcomes
Basic objectives2
Others
Basic objectives -Others
a prospective observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiovascular events
All cause death
Key secondary outcomes
Renal outcome
Hospitalization of heart failure
Fall and fracture
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
Hypertension
Diabetes mellitus
Dyslipidemia
Chronic kidney disease
Key exclusion criteria
Atrial fibrillation
Neurodegenerative disease
Cerebral infarction
Cerebral hemorrhage
Cardiac infarction
Dialysis patient
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yusuke Kobayashi |
Organization
The Kobayashi Medical Clinic
Division name
Internal medicine
Zip code
Address
2-2-2, Nakadaminami, Izumiku, Yokohama, Kanagawa
TEL
045-801-2551
yusuke.kob@live.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Kobayashi |
Organization
The Kobayashi Medical Clinic
Division name
Internal medicine
Zip code
Address
2-2-2, Nakadaminami, Izumiku, Yokohama, Kanagawa
TEL
045-801-2551
Homepage URL
yusuke.kob@live.jp
Sponsor or person
Institute
The Kobayashi Medical Clinic
Institute
Department
Personal name
Funding Source
Organization
The Kobayashi Medical Clinic
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 17 | 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
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | 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
Autonomic response on sit-to-stand orthostatic test
evaluate atherosclerosis using CAVI and carotid ultrasonography
observation of cardiovascular events
Management information
Registered date
| 2014 | Year | 09 | Month | 17 | Day |
Last modified on
| 2016 | Year | 09 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017661
