UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032421 |
|---|---|
| Receipt number | 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 16:59:59 |
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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
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
mipocch@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University, Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036723
