UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012990
Receipt No. R000015015
Scientific Title Association between reactive oxygen metabolites and severity of coronary artery disease and future cardiovascular events in coronary artery disease patients
Date of disclosure of the study information 2014/01/28
Last modified on 2015/02/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Association between reactive oxygen metabolites and severity of coronary artery disease and future cardiovascular events in coronary artery disease patients
Acronym Coronary artery disease and reactive oxygen merabolites
Scientific Title Association between reactive oxygen metabolites and severity of coronary artery disease and future cardiovascular events in coronary artery disease patients
Scientific Title:Acronym Coronary artery disease and reactive oxygen merabolites
Region
Japan

Condition
Condition Coronary artery disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the relationship between reactive oxygen metabolites and severity of coronary artery disease in patient with coronary artery disease and to investigate the prognostic involvement of reactive oxygen metabolites in the future cardiovascular events in patients with coronary artery disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Composite endopoint of cardiovascular death, non-fatal myocardial infarction, unstable angina pectoris, non-fatal ischemic stroke, re-hospitalization for heart failure, or coronary revascularization
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with symptoms of angina or suspected myocardial ischemia, and who were examined the presence of coronary artery disease by coronary angiography in Kumamoto University Hospital.
Key exclusion criteria Acute coronary syndrome
heart failure
Active infection diseases
History of malignancy
End stage of chronic kidney diseases
History of coronary artery bypass graft
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisao Ogawa
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Email cvmhisho@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihiro Hirata
Organization Graduate School of Medical Sciences, Kumamoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto City, JAPAN
TEL 81-96-373-5175
Homepage URL
Email yyyyyoshi25@yahoo.co.jp

Sponsor
Institute Kumamoto University
Institute
Department

Funding Source
Organization Kumamoto University
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
2014 Year 01 Month 28 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Reactive oxygen metabolites was significantly higher in severe/complex coronary artery disease patients and correlated with the occurrence of future cardiovascular events.
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 Completed
Date of protocol fixation
2007 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2007 Year 01 Month 18 Day
Last follow-up date
2014 Year 02 Month 18 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 04 Month 01 Day

Other
Other related information Patients were followed every month at the outpatient clinic until February 2014 or until an endpoint occured.

Management information
Registered date
2014 Year 01 Month 28 Day
Last modified on
2015 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.