UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007040 |
|---|---|
| Receipt number | R000007935 |
| Scientific Title | Prospective evaluation of endothelial function and myocardial damage in dialysis patients with coronary artery disease |
| Date of disclosure of the study information | 2012/01/09 |
| Last modified on | 2012/01/09 18:52:21 |
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Basic information
Public title
Prospective evaluation of endothelial function and myocardial damage in dialysis patients with coronary artery disease
Acronym
Evaluation of endothelial function and myocardial scintigraphy in dialysis patients
Scientific Title
Prospective evaluation of endothelial function and myocardial damage in dialysis patients with coronary artery disease
Scientific Title:Acronym
Evaluation of endothelial function and myocardial scintigraphy in dialysis patients
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of endothelial function in dialysis patients with ischemic heart disease
Basic objectives2
Others
Basic objectives -Others
Association between endothelial function and myocardial scintigraphy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Coronary spasm by acethylcoline test
2.Myocardial damage and mismatch assessed by 201Tl and 123I-BMIPP SPECT
3.Endothelial function assessed by endo-PAT or FMD
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
dialysis
ischemic heart disease
Key exclusion criteria
acute myocardial infarction
unstable angina pectoris
contrast media allergy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Nakashima |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
Address
1, Kanda Izumi-cho, Chiyoda-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Mitsui Memorial Hospital
Division name
Division of Cardiology
Zip code
Address
TEL
03-3862-9111
Homepage URL
Sponsor or person
Institute
Division of Cardiology, Mitsui Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 01 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective evaluation of endothelial dysfunction assessed by FMD/endo-PAT and acethylcoline test as well as association between their results and myocardial damage assessed by myocardial scintigraphy
Management information
Registered date
| 2012 | Year | 01 | Month | 09 | Day |
Last modified on
| 2012 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007935
| Research Plan | |
|---|---|
| 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 |
