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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033959
Receipt No. R000038590
Scientific Title Evaluation of the stability of circulating nucleotides and microvesicles as biomarkers for cardiovascular diseases
Date of disclosure of the study information 2018/11/20
Last modified on 2019/08/31

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Basic information
Public title Evaluation of the stability of circulating nucleotides and microvesicles as biomarkers for cardiovascular diseases
Acronym Evaluation of the stability of circulating nucleotides and microvesicles as biomarkers for cardiovascular diseases
Scientific Title Evaluation of the stability of circulating nucleotides and microvesicles as biomarkers for cardiovascular diseases
Scientific Title:Acronym Evaluation of the stability of circulating nucleotides and microvesicles as biomarkers for cardiovascular diseases
Region
Japan

Condition
Condition atrial fibrillation, atherosclerotic disease
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the stability of the circulating nucleotide as a biomarker for cardiovascular disease
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The diurnal change and the effect of diet in the expression level of circulating nucleotides.
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of food, one time
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1 Healthy subjects
2 Patients who regularly visiting Tokyo Medical and Dental University Medical hospital and who are diagnosed as having atrial fibrillation or endothelial dysfunction
Key exclusion criteria Subjects who have malignancy, autoimmune diseases, or severe anemia (Hb<10.9)
Target sample size 194

Research contact person
Name of lead principal investigator
1st name Tetsuo
Middle name
Last name Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 1138519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5231
Email sasano.bi@tmd.ac.jp

Public contact
Name of contact person
1st name Tetsuo
Middle name
Last name Sasano
Organization Tokyo Medical and Dental University
Division name Department of Cardiovascular Medicine
Zip code 1138519
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5231
Homepage URL
Email sasano.bi@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Ministry of education, culture, sports, science and technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel 03-5803-5096
Email syomu1.adm@tmd.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

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
2018 Year 09 Month 25 Day
Anticipated trial start date
2019 Year 03 Month 13 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 30 Day
Last modified on
2019 Year 08 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038590

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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