UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014802 |
|---|---|
| Receipt number | R000017215 |
| Scientific Title | Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis |
| Date of disclosure of the study information | 2014/08/09 |
| Last modified on | 2018/08/13 11:46:58 |
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Basic information
Public title
Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Acronym
Autonomic nervous system evaluation by real-time heart rate variability
Scientific Title
Usefulness of the autonomic nervous system evaluation by real-time heart rate variability analysis
Scientific Title:Acronym
Autonomic nervous system evaluation by real-time heart rate variability
Region
| Japan |
Condition
Condition
healthy Volunteer
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will evaluate the sympathetic activity by simultaneously performing for healthy volunteer "heart rate variability analysis method real-time" and the general analysis of muscle sympathetic nerve activity(MSNA).
Consequently, we can evaluate the autonomic nervous activity over time and instantaneous by the real-time heart rate variability analysis and demonstrate usefullness of its method.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlation between the number of times excitement and excitement frequency by (MSNA) muscle sympathetic and LF / HF rate of change by real-time heart rate variability analysis over time due to various stress or loads
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
evaluate the sympathetic nerve activity between MSNA and real-time heart rate valiability for healthy volinteer
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
participants (healthy volunteer), who could fully understand and agree all the contents of presenst study
Key exclusion criteria
Those whom the doctor or research investigator has determined to be inappropriate as a subject of the present study
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Tsutsui |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6970
htsutsui@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mamoru Sakakibara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
mike.s@ninus.ocn.ne.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Hokkaido University Graduate 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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 09 | 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
recruited 8 paitients and analyize the data about autonomic nerve activity
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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | Month | 12 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 09 | Day |
Last modified on
| 2018 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017215
