UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016651 |
|---|---|
| Receipt number | R000019320 |
| Scientific Title | The effect of vascular function in patients with cardiovascular disease. |
| Date of disclosure of the study information | 2015/02/26 |
| Last modified on | 2016/02/14 17:15:15 |
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Basic information
Public title
The effect of vascular function in patients with cardiovascular disease.
Acronym
The effect of vascular function
Scientific Title
The effect of vascular function in patients with cardiovascular disease.
Scientific Title:Acronym
The effect of vascular function
Region
| Japan |
Condition
Condition
Cardiovascular disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effct of vascular fuction for the clinical parameters (blood sample, ECG, UCG, CT, MRI, IVUS, OCT, etc) and prognosis in patients with cardiovascular disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
prognosis
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
1)Patients with cardiovascular disease.
2)Patients providing written consent for participation in this study on their own volition after receving a through explanation about the study.
Key exclusion criteria
1) Patients with unwillingness to
participate or Patients whose conset could not be aquired.
2)Patients judged to be unsuitable for participation for medical reason.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Kimura |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
+81-45-261-5656
c-kimura@urahp.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaomi Gohbara |
Organization
Yokohama City University Medical Center
Division name
Division of Cardiology
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL
+81-45-261-5656
Homepage URL
gocchi3@hotmail.com
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2015 | Year | 02 | Month | 26 | 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
We analyzed the patients limitted to acute coronary syndrome (scheduled sample size was 285) in regard to CAVI, and submitted a paper to a journal.
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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To assess the impact of vascular function determined by CAVI, ba-PWV, and EndoPAT on the prognosis.
Management information
Registered date
| 2015 | Year | 02 | Month | 26 | Day |
Last modified on
| 2016 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019320
