UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019646 |
|---|---|
| Receipt number | R000022693 |
| Scientific Title | Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period. |
| Date of disclosure of the study information | 2015/11/08 |
| Last modified on | 2019/09/19 10:47:47 |
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Basic information
Public title
Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Acronym
Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Scientific Title
Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Scientific Title:Acronym
Evaluation of autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Region
| Japan |
Condition
Condition
The patients who performed operation for cardiovascular disease
Classification by specialty
| Cardiovascular surgery | Nursing | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate autonomic nervous activity in patients who performed operation for cardiovascular disease in postoperative period.
Basic objectives2
Others
Basic objectives -Others
To elucidate whether postoperative autonomic nervous activity recover in patients with cardiovascular disease or not.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Temporal changes in autonomic nervous activity in postoperative period
Key secondary outcomes
To investigate whether temporal changes in autonomic nervous activity could be related to onset of postoperative atrial fibrillation or not.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
ECG data is recorded in preoperative period once in supine position for fifteen minutes. In postoperative period, its recording continues from postoperative day 1 to postoperative day 7. After that, the recording performs at two or three day intervals until the patients discharge.
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
The patients who performed operation for cardiovascular disease.
Key exclusion criteria
The patients who needs urgent hospitalization.
The patients with pacemaker.
The patients with atrial fibrillation in preoperative period.
The patients with frequent arrhythmia such as premature atrial or ventricle contraction.
The patients with dialysis.
The patients with ventricular assist device.
The patients with dementia.
The patients that decision making is impossible.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
981-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
02271717222
konosuke.s@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Konosuke |
| Middle name | |
| Last name | Sasaki |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of cardiovascular surgery
Zip code
981-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
TEL
02271717222
Homepage URL
konosuke.s@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University School of Medicine
Address
2-1, Seiryo-machi, Aoba-ku, Sendai
Tel
0227284105
med-kenkyo@grp.tohoku.ac.jp
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 | 11 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 11 | Month | 05 | Day |
Last modified on
| 2019 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022693
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
