UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004129 |
|---|---|
| Receipt number | 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 17:52:48 |
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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
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
tshioi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004958
