UMIN-CTR Clinical Trial

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
Email	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
Email	rtoh@med.kobe-u.ac.jp

Sponsor
Institute	Division of cardiovascular medicine, Kobe university graduate school of medicine.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034596