UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019223 |
|---|---|
| Receipt number | R000022116 |
| Scientific Title | Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit |
| Date of disclosure of the study information | 2015/10/10 |
| Last modified on | 2015/10/03 10:24:36 |
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Basic information
Public title
Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Acronym
Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Scientific Title
Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Scientific Title:Acronym
Sleep,hemodynamics and autonomic activations in patients in the cardiovascular care unit
Region
| Japan |
Condition
Condition
cardiovascular diseases in acute management
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to reveal the influence of the rest by sleeping on sympathetic activities and hemodynamic changes in patients in cardiovascular care unit.
Basic objectives2
Others
Basic objectives -Others
The relationship between the rest by sleeping, sympathetic activity and hemodynamic changes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sympathetic activity and hemodynamic changes during sleep in patients in cardiovascular care unit.
Key secondary outcomes
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･admission to cardiovascular care unit
･necessity for intra-arterial line for therapeutic purposes
･consent to participate in this study
Key exclusion criteria
･inability to give consent(e.g. endotracheal intubation,remarkable dementia)
･requirement of intravenous beta-blocking agents
･taking alpha-blockers
･requirement of intravenous inotropes
･being artificially paced
･frequent arrhythmias(e.g. atrial fibrillation)
･requirement of intra-aortic balloon pumping
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saki Hasegawa |
Organization
Saitama Medical University, International Medical Center
Division name
Cardiology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
h_hase@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saki Hasegawa |
Organization
Saitama Medical University, International Medical Center
Division name
Cardiology
Zip code
Address
1397-1, Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
h_hase@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University, International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University, International Medical Center
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
| 2015 | Year | 10 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 10 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is prospective observational study about patients admitted to CCU from October 2015.
Management information
Registered date
| 2015 | Year | 10 | Month | 03 | Day |
Last modified on
| 2015 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022116
| Research Plan | |
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| 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 |
