UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study to evaluate the role of proinflammatory cytokines in acute myocardial infarction
Title of the study (Brief title)	A clinical study on the inflammation in acute myocardial infarction
Region	Japan

Condition
Condition	acute myocardial infarction
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine the role of proinflammatory cytokines in the pathogenesis of left ventricular remodeling after acute myocardial infarction
Basic objectives2	Others
Basic objectives -Others	to examine the clinical significance of the elevation of serum proinflammatory cytokine level
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	in hospital and out of hospital clinical complications (pump failure, cardiac rupture, VT/VF, cardiac death)
Key secondary outcomes	left ventricular remodeling (echocardiography and left ventriculography) biomarker (white blood cell counts, CK, CRP, BNP, proinflammatory cytokines)

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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	patients with first ST-elevation acute myocardial infarction, in whom time elapsed from onset to admission was within 24 hours
Key exclusion criteria	infectious disease, collagen disease, malignancy, advanced liver disease, and renal failure
Target sample size	150

Research contact person
Name of lead principal investigator	Takashi Kohno
Organization	Keio University School of Medicine, Department of Medicine
Division name	Division of Cardiology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	033531211
Email	kohno.ta@gmail.com

Public contact
Name of contact person	Takashi Kohno
Organization	Keio University School of Medicine, Department of Medicine
Division name	Division of Cardiology
Address	35 Shinanomachi Shinjuku-ku
TEL	03-5363-3793
Homepage URL
Email	kohno.ta@gmail.com

Sponsor
Institute	Keio University School of Medicine, Department of Medicine, Division of Cardiology
Institute
Department

Funding Source
Organization	Office of research administration at Shinanomachi, Keio University
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	2012 Year 03 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 02 Month 09 Day
Anticipated trial start date	2008 Year 02 Month 09 Day
Last follow-up date	2011 Year 12 Month 31 Day
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	prospective cohort study

Management information
Registered date	2008 Year 02 Month 09 Day
Last modified on	2017 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001232