UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024724 |
|---|---|
| Receipt number | R000028445 |
| Scientific Title | The study to elucidate the mechanism of pathogenesis of atrial fibrillation targeting mitochondria in atrial myocardium |
| Date of disclosure of the study information | 2016/11/08 |
| Last modified on | 2025/05/12 20:27:40 |
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Basic information
Public title
The study to elucidate the mechanism of pathogenesis of atrial fibrillation targeting mitochondria in atrial myocardium
Acronym
AFMITO Study
Scientific Title
The study to elucidate the mechanism of pathogenesis of atrial fibrillation targeting mitochondria in atrial myocardium
Scientific Title:Acronym
AFMITO Study
Region
| Japan |
Condition
Condition
Atrial fibrillation
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the hypothesis that impaired mitochondrial oxidative phosphorylation capacity and mitochondrial oxidative stress in atrial myocardium might contribute to pathogenesis and development of atrial fibrillation
Basic objectives2
Others
Basic objectives -Others
To elucidate the mechanism of pathogenesis and development of atrial fibrillation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mitochondrial oxidative phosphorylation capacity and mitochondrial reactive oxygen species (ROS) release in atrial myocardium
Key secondary outcomes
1.Systemic oxidative stress
2.Systemic inflammation
3.Intramyocellular lipid in atrial myocardium
4.Mitochondrial density in atrial myocardium
5.Gene expression and protein content in atrial myocardium
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
Patients with cardiovascular disease who will undergo incision of right atrium in open-heart surgery
Key exclusion criteria
1. Patients who cannot give written informed consent
2. Patients who are considered inappropriate for the study by the principal investigator
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
t-yokota@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yokota |
Organization
Faculty of Medicine and Graduate School of Medicine, Hokkaido University
Division name
Department of Cardiovascular Medicine
Zip code
060-8638
Address
Kita-15 Nishi-7, Kita-Ku, Sapporo, Japan
TEL
011-706-6973
Homepage URL
t-yokota@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teine Keijinkai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hokkaido University Hospital
Address
Kita-14 Nishi-5, Kita-Ku, Sapporo 060-8648, Japan
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2016 | Year | 11 | Month | 08 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 05 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 08 | 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
1. Observational study
2. Case-control study
Management information
Registered date
| 2016 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028445
