UMIN-CTR Clinical Trial

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019872
Receipt No. R000022812
Scientific Title Relationship between Mitochondrial DNA Damage and Atherosclerosis
Date of disclosure of the study information 2015/11/20
Last modified on 2019/05/24 (Ver. 6)

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Basic information
Public title Relationship between Mitochondrial DNA Damage and Atherosclerosis
Acronym Mitochondrial DNA Damage and Atherosclerosis
Scientific Title Relationship between Mitochondrial DNA Damage and Atherosclerosis
Scientific Title:Acronym Mitochondrial DNA Damage and Atherosclerosis
Region
Japan

Condition
Condition Healthy volunteer, patietns with hypertension, dyslipidemia, diabetes, chronic kidney disease, peripheral artery disease, coronary heart disease, cerebrovascular disease, or heart failure, and current smoker.
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association of mtDNA damage level with conventional cardiovascular risk factors such as hypertension, diabetes, and dyslipidemia to determine whether mtDNA damage level is a useful marker of atherosclerosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1)The association between mtDNA damage level and conventional cardiovascular risk factors.
(2) The association between mtDNA damage level and endothelial function.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer, patients with hypertension, dyslipidemia, diabetes, chronic kidney disease, peripheral artery disease, coronary artery diesase, cerebrovascular disease or heart failure, and current smoker.
Key exclusion criteria Patients who are considered not eligible for the study by the attending doctor.
Target sample size 1000

Research contact person
Last name of lead principal investigator
1st name Yukihito
Middle name
Last name Yukihito
Organization Research Institute for Radiation Biology and Medicine, Hiroshima University
Division name Department of Cardiovascular Regeneration and Medicine
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5831
Email yhigashi@hiroshima-u.ac.jp

Public contact
1st name of contact person
1st name Tatsuya
Middle name
Last name Tatsuya
Organization Hiroshima University
Division name Department of Cardiovascular Medicine, Graduate School of Biomedical & Health Sciences
Zip code 734-8551
Address 1-2-3 Kasumi, Minami-ku, Hiroshima
TEL 082-257-5540
Homepage URL
Email 55maruchin@gmail.com

Sponsor
Institute Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department

Funding Source
Organization Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University
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 IRB of Hiroshima University
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
Tel 082-257-5907
Email kasumi-kenkyu@office.hiroshima-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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 20 Day

Related information
URL releasing protocol not released
Publication of results Unpublished

Result
URL related to results and publications not released
Number of participants that the trial has enrolled 175
Results 
We enrolled 175 subjects. We assessed the associations of mtDNA with traditional risk factors and flow-mediated vasodilation. However, there was no significant associations between them, indicating that mtDNA may not be useful as a marker of atherosclerosis.
Results date posted
2019 Year 05 Month 24 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Patients with coronary risk factors
Participant flow 
We enrolled 175 patients from outpatient clinic.
Adverse events 
none
Outcome measures 
We assessed the associations of mtDNA with traditional risk factors and flow-mediated vasodilation. However, there was no significant associations between them.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2015 Year 09 Month 03 Day
Date of IRB
2015 Year 09 Month 03 Day
Anticipated trial start date
2015 Year 12 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1)Cross-sectional study
(2)We enroll subjects who visit our hospital from December 2015 to March 2018 and meet the inclusion criteria.
(3)We measure mtDNA damage level, endothelial function, blood pressure, lipid profile, and glucose level.

Management information
Registered date
2015 Year 11 Month 20 Day
Last modified on
2019 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022812