UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030297 |
|---|---|
| Receipt number | R000034596 |
| Scientific Title | Investigation of blood-based biomarkers for cardiovascular disease |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2021/03/31 15:05:24 |
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Basic information
Public title
Investigation of blood-based biomarkers for cardiovascular disease
Acronym
Kobe Cardiovascular Marker Investigation Registry (Kobe CMI registry)
Scientific Title
Investigation of blood-based biomarkers for cardiovascular disease
Scientific Title:Acronym
Kobe Cardiovascular Marker Investigation Registry (Kobe CMI registry)
Region
| Japan |
Condition
Condition
Cardiovascular diseases (Acute coronary syndrome, Arteriosclerotic disease, Valvular heart disease, Chronic heart failure, Arrhythmic disease, Deep vein thrombosis, Pulmonary embolism, Pulmonary hypertension)
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identification of blood-based biomarkers that have utility in predicting cardiovascular disease.
Basic objectives2
Others
Basic objectives -Others
Pathophysiology
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Association between candidate markers and incidence rate of cardiovascular disease
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 cardiovascular disease who are hospitalized or received outpatient care at cardiovascular internal medicine, Kobe university hospital on or after April 2008.
Key exclusion criteria
Patients who do not provide written consent for participation in this study.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Hirata |
| Middle name | |
| Last name | Ken-ichi |
Organization
Kobe university graduate school of medicine
Division name
Division of cardiovascular medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo 650-0017
TEL
078-382-5846
hiratak@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Toh |
| Middle name | |
| Last name | Ryuji |
Organization
Kobe university graduate school of medicine
Division name
Evidence-based Laboratory Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo 650-0017
TEL
078-382-5846
Homepage URL
rtoh@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of cardiovascular medicine, Kobe university graduate school of medicine.
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
Kobe university hospital clinical and translational research center, IRB office
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, 650-0017
Tel
078-382-6669
chiken@med.kobe-u.ac.jp
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
神戸大学医学部付属病院 / Kobe university hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2008 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
End point:
1. Relationship between cardiovascular event rate and lipid-related markers including endothelial lipase, Apo B48, Trans-fatty acid, HDL cholesterol uptake capacity or inflammatory and oxidative stress markers in blood or urine.
2. Identification of disease-specific biomarkers by proteome and metabolome analysis.
3. Relationship between candidate biomarkers and dietary factors
4. Relationship between candidate biomarkers and findings in various imaging diagnostic tests including coronary angiography, intracoronary optical coherence tomography, intravascular ultrasound, CT, MRI and echocardiogram.
5. Therapeutic response monitoring using candidate biomarkers.
6. Changes in candidate biomarkers before and after cardiovascular interventions.
7. Analysis of gene expression or gene polymorphism which may be related to candidate biomarkers.
Management information
Registered date
| 2017 | Year | 12 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034596
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
