UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022867 |
|---|---|
| Receipt number | R000026286 |
| Scientific Title | Retrospective observational study examining the effects of endothelial function on the prognosis |
| Date of disclosure of the study information | 2016/06/24 |
| Last modified on | 2016/06/24 10:28:32 |
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Basic information
Public title
Retrospective observational study examining the effects of endothelial function on the prognosis
Acronym
Retrospective observational study examining the effects of endothelial function on the prognosis
Scientific Title
Retrospective observational study examining the effects of endothelial function on the prognosis
Scientific Title:Acronym
Retrospective observational study examining the effects of endothelial function on the prognosis
Region
| Japan |
Condition
Condition
diabetes mellitus
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prove the efficacy of the endothelial function as a predictor of cardiovascular prognosis by retrospective observation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Relationship between endothelial function and composite cardiovascular events that occurred after the endothelial function measurement.
Key secondary outcomes
1. All death.
2. Composite cardiovascular events and peripheral artery disease.
3. Composite cardiovascular events, peripheral artery disease and
heart failure.
4. The induction of hemodialysis.
5. The rate of decrease in eGFR.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The series of 1400 consecutive patients performed endothelial function tests from January 2005 to December 2015 in at the department of medicine in Shiga University Hospital. They were performed under the following conditions.
1. Able to keep resting position of the whole body and upper limbs.
2. No arrhythmia
3. All test was performed by only one clinical laboratory technician throughout the study.
Key exclusion criteria
This study is a retrospective observational study, carried out by the opt-out method of our hospital website. We have excluded the case, which we determined inaccuracy due to multiple arrhythmia and poor physical condition on the test day.
Target sample size
1400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsutaro Morino |
Organization
Shiga University of Medical Science
Division name
Department of Medicine, Division of Diabetes, Nephrology and Neurology
Zip code
Address
Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL
077-548-2222
morino@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsutaro Morino |
Organization
Shiga University of Medical Science
Division name
Department of Diabetes, Nephrology and Neurology
Zip code
Address
Seta Tsukinowa, Otsu, Shiga, Japan 520-2192
TEL
077-548-2222
Homepage URL
http://www.shiga-med.ac.jp/hospital/doc/department/department/secretion/index.html
sumsdmg@gmail.com
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
| 2016 | Year | 06 | Month | 24 | 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
| 2016 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | 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
The main observation items:
1. The endotherial function
2. Composite cardiovascular events.
3. All death.
4. Composite cardiovascular events and peripheral artery disease.
5. Composite cardiovascular events, peripheral artery disease and heart failure.
6. The induction of hemodialysis.
7. The rate of decrease in eGFR.
Management information
Registered date
| 2016 | Year | 06 | Month | 24 | Day |
Last modified on
| 2016 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026286
