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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032421
Receipt No. R000036723
Scientific Title Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Date of disclosure of the study information 2018/05/30
Last modified on 2018/04/28

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Basic information
Public title Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Acronym Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Scientific Title Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Scientific Title:Acronym Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Region
Japan

Condition
Condition cardiovascular disease
Classification by specialty
Cardiology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the involvement of oxidative stress and glycative stress in cardiovascular disease patients by simultaneously measuring urine 8 - OHdG and AGEs accumulation in skin or subcutaneous tissue
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Major cardiovascular events (acute coronary syndrome, revascularization, heart failure, stroke, other hospitalization), death
occurring one year and three years later
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 Patients who understand this study and obtained document agreement by intention of patient themselves
Key exclusion criteria 1.Patients with severe complications that are problematic when participating in this study, such as amputation of limbs, severe skin complications
2.Patients judged that examination responsibility doctor is improper as object in present study
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Shimada
Organization Juntendo University, Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address 2-1-1 Hongo,Bunkyo-ku Tokyo Japan
TEL 03-3813-3111
Email shimakaz@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Miho Yokoyama
Organization Juntendo University, Graduate School of Medicine
Division name Department of Cardiovascular Medicine
Zip code
Address Department of Cardiovascular Medicine
TEL 03-3813-3111
Homepage URL
Email mipocch@juntendo.ac.jp

Sponsor
Institute Juntendo University, Graduate School of Medicine
Institute
Department

Funding Source
Organization Juntendo University, Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
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
2018 Year 05 Month 30 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 Enrolling by invitation
Date of protocol fixation
2018 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 18 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study.
<Study subjects>
The patients with cardiovascular disease who are visiting or hospitalized for Juntendo University Hospital, Department of Cardiology are targeted.

1 Coronary artery disease
2 Valvular disease
3 Heart failure
4 Arrhythmia
5 Aortic disease
6 Peripheral artery disease
7 Cerebrovascular disease

Management information
Registered date
2018 Year 04 Month 28 Day
Last modified on
2018 Year 04 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036723

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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