UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015135 |
|---|---|
| Receipt number | R000017599 |
| Scientific Title | Association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery. |
| Date of disclosure of the study information | 2014/09/24 |
| Last modified on | 2017/09/13 16:06:13 |
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Basic information
Public title
Association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery.
Acronym
Association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery.
Scientific Title
Association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery.
Scientific Title:Acronym
Association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery.
Region
| Japan |
Condition
Condition
disease requiring cardiovascular surgery
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and perioperative complications in cardiovascular sugery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perioperative complications in cardiovascular sugery such as death, reoperation, newly dialysis required, deep sternum infection, stroke, prolonged ventilation(>72h or re-intubation).
Key secondary outcomes
association between endothelial function assessed by reactive hyperemia-peripheral arterial tonometry and preoperative tests, mid- and long- term prognosis, post-operative atrial fibrillation, or period of hospitalization.
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
Patients who undergo elective cardiovascular surgery.
Key exclusion criteria
Patients of hemodialysis, without concent or who are assessed ineligible.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Kobayashi |
Organization
Chiba University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
tsuchiya-chiba@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Saito |
Organization
Chiba University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL
043-222-7171
Homepage URL
y-saito@chiba-u.jp
Sponsor or person
Institute
Chiba University School of Medicine Department of Cardiovascular 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 | 09 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2014 | Year | 09 | Month | 11 | Day |
Last modified on
| 2017 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017599
