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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010147
Receipt No. 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

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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
Email 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
Email m.katsuomi@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011884

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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