UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022274 |
|---|---|
| Receipt number | R000025656 |
| Scientific Title | Relation of plasma xanthine oxidation-reduction enzyme activity and various factors in patients with cardiovascular disease and/or heart failure |
| Date of disclosure of the study information | 2016/05/11 |
| Last modified on | 2020/11/13 10:52:21 |
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Basic information
Public title
Relation of plasma xanthine oxidation-reduction enzyme activity and various factors in patients with cardiovascular disease and/or heart failure
Acronym
Xanthine oxidation-reduction enzyme activity in patients with cardiovascular disease
Scientific Title
Relation of plasma xanthine oxidation-reduction enzyme activity and various factors in patients with cardiovascular disease and/or heart failure
Scientific Title:Acronym
Xanthine oxidation-reduction enzyme activity in patients with cardiovascular disease
Region
| Japan |
Condition
Condition
cardiovascular disease
heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the plasma XOR activity in the patients with cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
To evaluate the plasma XOR activity in the patients with heart failure.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Measured value of the plasma XOR activity in patients with cardiovascular disease
Key secondary outcomes
Measured value of the plasma XOR activity in patients with heart failure
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
Male or female patients over 20 years old at time the subjects sign the Informed Consent Form (ICF).
Key exclusion criteria
Patients who are judged as inappropriate for inclusion by physicians.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobukazu Ishizaka |
Organization
Osaka Medical College
Division name
Department of Cardiology
Zip code
Address
2-7 Daigakucho, Takatuski, Osaka
TEL
072-683-1221
ishizaka@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Kanzaki |
Organization
Osaka Medical College
Division name
Department of Cardiology
Zip code
Address
2-7 Daigakucho, Takatuski, Osaka
TEL
072-683-1221
Homepage URL
in3089@poh.osaka-med.ac.jp
Sponsor or person
Institute
Department of Cardiology
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
SANWA KAGAKU KENKYUSHO CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
SANWA KAGAKU KENKYUSHO CO.,LTD
Name of secondary funder(s)
not applicable
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 | 05 | Month | 11 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 05 | Month | 11 | Day |
Last modified on
| 2020 | Year | 11 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025656
