UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014429 |
|---|---|
| Receipt number | R000016794 |
| Scientific Title | Investigation for Association of Adiponectin and Acute Coronary Syndrome |
| Date of disclosure of the study information | 2020/01/01 |
| Last modified on | 2020/01/14 18:59:23 |
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Basic information
Public title
Investigation for Association of Adiponectin and Acute Coronary Syndrome
Acronym
i4ACS
Scientific Title
Investigation for Association of Adiponectin and Acute Coronary Syndrome
Scientific Title:Acronym
i4ACS
Region
| Japan |
Condition
Condition
Acute myocardial infarction, Angina pectoris
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the significance of circulating factors relating to life style-associated diseases.
Basic objectives2
Others
Basic objectives -Others
To clarify the difference of concentrations in circulating factors in coronary and aortic blood
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significance of circulating factors relating to life style-associated diseases.
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
Subjects who were diagnosed as acute myocardial infection or angina pectoris, and then treated by PCI. Subjects agreed with study protocol.
Key exclusion criteria
(1) Cases with significant stenosis in the left main trunk (LMT) or with post-CABG or with post-intracoronary stenting or with pioglitazone treatment.
(2) Subjects who were judged inadequate for the study by the attending physician.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iichiro Shimomura |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
ichi@endmet.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Maeda |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Metabolic Medicine
Zip code
Address
2-2-B5, Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-3737
Homepage URL
norikazu_maeda@endmet.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Metabolic Medicine,
Graduate School of Medicine, Osaka
University
Institute
Department
Personal name
Funding Source
Organization
Department of Metabolic Medicine,
Graduate School of Medicine, Osaka
University
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
| 2020 | Year | 01 | 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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 10 | Month | 30 | Day |
Other
Other related information
Measurement of adipocytokines, oxidative stresses, and factors relating to atherosclerosis.
Management information
Registered date
| 2014 | Year | 06 | Month | 30 | Day |
Last modified on
| 2020 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016794
