UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010432 |
|---|---|
| Receipt number | R000011935 |
| Scientific Title | Incremental Impact of Peripheral Endothelial Function on Coronary Artery Disease and Cardiovascular Events in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2013/04/05 |
| Last modified on | 2015/02/01 22:34:52 |
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Basic information
Public title
Incremental Impact of Peripheral Endothelial Function on Coronary Artery Disease and Cardiovascular Events in Patients with Chronic Kidney Disease
Acronym
Peripheral Endothelial Function and Coronary Artery Disease, and Cardiovascular Events
Scientific Title
Incremental Impact of Peripheral Endothelial Function on Coronary Artery Disease and Cardiovascular Events in Patients with Chronic Kidney Disease
Scientific Title:Acronym
Peripheral Endothelial Function and Coronary Artery Disease, and Cardiovascular Events
Region
| Japan |
Condition
Condition
Chronic Kidney Disease
Coronary Artery Disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between endothelial dysfunction and coronary artery disease, cardiovascular events in patient with chronic kidney disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for heart failure, or coronary revascularization
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
stable patients with at least one coronary risk factor(diabetes, hypertension, dyslipidemia, family history of coronary artery disease)
Key exclusion criteria
Severe valvular disease
History of malignancy
Severe collagen disease
CKD patients who underwent Hemodialysis
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto City, JAPAN
TEL
81-96-373-5175
ssugiyam@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiro Hirata |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-1-1 Honjo, Kumamoto City, JAPAN
TEL
81-96-373-5175
Homepage URL
yyyyyoshi25@yahoo.co.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Kumamoto University
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
| 2013 | Year | 04 | Month | 05 | 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
Endothelial function was significantly impaired in CKD patients and correlated with the presence of CAD. Furthermore, endothelial function was a independent predictor of future cardiovascular events in CKD patients.
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
| 2006 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2013 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 11 | Month | 15 | Day |
Other
Other related information
Patients were followed prospectively every month at the outpatient clinic until October 2013 or until an endpoint occurred
Management information
Registered date
| 2013 | Year | 04 | Month | 05 | Day |
Last modified on
| 2015 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011935
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
