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UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004129
Receipt No. R000004958
Scientific Title Identification of novel biomarker of heart failure by collecting blood samples from coronary sinus, subclavian vein, and radial artery
Date of disclosure of the study information 2010/09/01
Last modified on 2010/08/30

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Basic information
Public title Identification of novel biomarker of heart failure by collecting blood samples from coronary sinus, subclavian vein, and radial artery
Acronym Identification of novel biomarker of heart failure by collecting blood samples from coronary sinus, subclavian vein, and radial artery
Scientific Title Identification of novel biomarker of heart failure by collecting blood samples from coronary sinus, subclavian vein, and radial artery
Scientific Title:Acronym Identification of novel biomarker of heart failure by collecting blood samples from coronary sinus, subclavian vein, and radial artery
Region
Japan

Condition
Condition heart failure
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study, we will collect blood samples from coronary sinus, subclavian vein, and radial artery. We will measure blood concentrations of the following molecules, known biomarkers of heart failure; multiple metabolites by use of metabolome analysis; and other potential molecules served as biomarkers of heart failure.
Basic objectives2 Others
Basic objectives -Others Minimally invasive clinical study by collecting blood samples in routine clincal practice
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We will measure the blood concentration of the potential biomarkers of heart failure in radial artery, coronary sinus, and subclavian vein. The difference in blood concentration of coronary sinus and radial artery will also be analyzed.
The concentrations of potential biomarker molecules will be compared with survival, severity of heart failure, electrocardiography, chest X-ray, blood chemical analyses, known biomarkers of heart failure, echocardiography, cardiac function assessed by radioisotope or MR imaging.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 We will collect 10mL of blood from radial artery, coronary sinus, and subclavian vein, in patients with heart failure receiving cardiac resynchronization therapy (CRT)
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
10 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Patients with heart failure receiving cardiac resynchronization therapy (CRT) at Kyoto University Hospital.
Key exclusion criteria none
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takeshi Kimura
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address 54 Shogoin- Kawahara-cho, Sakyo-ku, Kyoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Graduate School of Medicine, Kyoto University
Division name Department of Cardiovascular Medicine
Zip code
Address
TEL
Homepage URL
Email tshioi@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department

Funding Source
Organization Grant in aid for scientific research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2010 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 10 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

Management information
Registered date
2010 Year 08 Month 30 Day
Last modified on
2010 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004958

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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