UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025677 |
|---|---|
| Receipt number | R000026156 |
| Scientific Title | Anesthetic drugs effect myocardial protection for ischemia-reperfusion injury on human atrial tissue. |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2021/01/20 13:41:54 |
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Basic information
Public title
Anesthetic drugs effect myocardial protection for ischemia-reperfusion injury on human atrial tissue.
Acronym
Anesthetic drugs effect myocardial protection for ischemia-reperfusion injury on human atrial tissue.
Scientific Title
Anesthetic drugs effect myocardial protection for ischemia-reperfusion injury on human atrial tissue.
Scientific Title:Acronym
Anesthetic drugs effect myocardial protection for ischemia-reperfusion injury on human atrial tissue.
Region
| Japan |
Condition
Condition
valve disease, coronary artery disease, aortic aneurysm, aortic dissection
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We detect the effect of the myocardiac protection on human atrial muscle on operation. We investigate the effect of the calcium paradox or the oxgen paradox on the cell of human atrial muscle with inhalation anesthetic drugs(sevoflurane, desflurane), intravenous anesthetic drugs(propofol, midazolam, dexmedetomidine), narcotic drugs(fentanyl, remifentanil, morphine).
Basic objectives2
Others
Basic objectives -Others
In addition, we investigate these anesthetic effects on TRPC(transient receptor protential canonical) in regard to the calcium paradox or the effect on L-type calcium channel in regard to the oxgen paradox.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The difference of intraceller electric current with patch clamp method.
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the case that right uppendage is resected when extracorporeal membrane oxygenation starts.
Key exclusion criteria
the expansion of right atrium.
Target sample size
54
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Kitagawa |
Organization
Shiga University of Medical Science
Division name
anesthesiology
Zip code
Address
Tukinowa town Seta Otu city Shiga prefecture
TEL
077-548-2111
mshimizu@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Kitagawa |
Organization
Shiga University of Medical Science
Division name
anesthesiology
Zip code
Address
Tukinowa town Seta Otu city Shiga prefecture
TEL
077-548-2281
Homepage URL
hqanes@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
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
| 2017 | Year | 02 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
no special affairs
Management information
Registered date
| 2017 | Year | 01 | Month | 14 | Day |
Last modified on
| 2021 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026156
| Research Plan | |
|---|---|
| Registered date | File name |
| 2017/01/14 | document.s.161221.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
