UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010147 |
|---|---|
| Receipt number | R000011884 |
| Scientific Title | Urinary biomarkers: potential association with clinical features in patients with contrast-induced nephropathy who undergo percutaneous coronary intervention. |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2016/07/26 12:50:23 |
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Basic information
Public title
Urinary biomarkers: potential association with clinical features in patients with contrast-induced nephropathy who undergo percutaneous coronary intervention.
Acronym
Urinary biomarkers for contrast-induced nephropathy in PCI
Scientific Title
Urinary biomarkers: potential association with clinical features in patients with contrast-induced nephropathy who undergo percutaneous coronary intervention.
Scientific Title:Acronym
Urinary biomarkers for contrast-induced nephropathy in PCI
Region
| Japan |
Condition
Condition
acute myocardial infarction
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate the utility of urinary L-FABP compared with other urinary parameters for the early detection of post CI-AKI and to evaluate the prognosis among adult patients undergoing PCI.
Basic objectives2
Others
Basic objectives -Others
observational study
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
CI-AKI
prognosis
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients undergoing PCI in the St. Marianna University School of Medicine were eligible for enrollment.
AMI patients who undergo PCI a couple of times within two weeks.
Key exclusion criteria
1 AMI with fatal condition (Forrester4 arrhythmia, cardiac rupture)
2 Dialysis patient
3 Patients who undergo contrast study within last 14days
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
044-977-8111
m.katsuomi@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsuomi Matsui |
Organization
St. Marianna University School of Medicine
Division name
Department of Nephrology and Hypertension, Internal Medicine
Zip code
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki 216-8511, Japan
TEL
044-977-8111
Homepage URL
m.katsuomi@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of 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
| 2013 | Year | 04 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
a
Management information
Registered date
| 2013 | Year | 03 | Month | 01 | Day |
Last modified on
| 2016 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011884
