UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Urinary biomarkers: potential association with clinical features in patients with contrast-induced nephropathy who undergo percutaneous coronary intervention.
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Katsuomi Matsui
Organization	St. Marianna University School of Medicine
Division name	Department of Nephrology and Hypertension, Internal Medicine
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	Katsuomi Matsui
Organization	St. Marianna University School of Medicine
Division name	Department of Nephrology and Hypertension, Internal Medicine
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 02 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000011884