UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019872 |
|---|---|
| Receipt number | 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 18:39:49 |
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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
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
yhigashi@hiroshima-u.ac.jp
Public contact
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
55maruchin@gmail.com
Sponsor or person
Institute
Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022812
| Research Plan | |
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| Registered date | File name |
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