UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of involvement of oxidative stress and glycative stress in patients with cardiovascular disease
Title of the study (Brief title)	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	Kazunori Shimada
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
Address	2-1-1 Hongo,Bunkyo-ku Tokyo Japan
TEL	03-3813-3111
Email	shimakaz@juntendo.ac.jp

Public contact
Name of contact person	Miho Yokoyama
Organization	Juntendo University, Graduate School of Medicine
Division name	Department of Cardiovascular Medicine
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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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