UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004575 |
|---|---|
| Receipt number | R000005464 |
| Scientific Title | Osaka Acute Coronary Insufficiency Study |
| Date of disclosure of the study information | 2010/11/17 |
| Last modified on | 2010/11/17 03:05:53 |
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Basic information
Public title
Osaka Acute Coronary Insufficiency Study
Acronym
OACIS
Scientific Title
Osaka Acute Coronary Insufficiency Study
Scientific Title:Acronym
OACIS
Region
| Japan |
Condition
Condition
Acute Coronary Syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the background, management, and clinical outcomes in patients with acute coronary syndrome in Japan
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the clinical background, management, and outcomes of acute coronary syndrome
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
| 0 | years-old | <= |
Age-upper limit
| 150 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients who were diagnosed as acute coronary syndrome
Key exclusion criteria
NONE
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Issei Komuro |
Organization
Osaka University Graduate School of Midicine
Division name
Department of Cradiovascular Medicine
Zip code
Address
2-2 Yamada-oka, Suita 5650871 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sakata |
Organization
Osaka University Graduate School of Midicine
Division name
Department of Cradiovascular Medicine
Zip code
Address
2-2 Yamada-oka, Suita 5650871 JAPAN
TEL
Homepage URL
Sponsor or person
Institute
Department of Cradiovascular Medicine
Osaka University Graduate School of Midicine
Institute
Department
Personal name
Funding Source
Organization
Department of Cradiovascular Medicine
Osaka University Graduate School of Midicine
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
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
| 2010 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 1998 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1998 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The Osaka Acute Coronary Insufficiency Study (OACIS) is a prospective, multi-center observational study designed to collect and analyze demographic, procedural, outcome data, and blood samples in patients with AMI at 25 collaborating hospitals in the Osaka region of Japan. Cardiologists and specialized research nurses recorded data on socio-demographic variables, medical histories, therapeutic procedures, and clinical events during patient hospitalization, and also obtained follow-up clinical data at 3, 6, and 12 months after the occurrence of AMI, and annually thereafter. Information was obtained from hospital medical records and by direct interviews with patients, their family members, and their treating physicians. All data were transmitted to the data collection center at the Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Suita, Japan for processing and analysis. The diagnosis of AMI required the presence of two of the following three criteria: (1) history of central chest pressure, pain, or tightness lasting􏰸30 min, (2) ST-segment elevation 0.1 mV in 1 limb lead or 2 precordial leads, and (3) an increase in serum creatine kinase (CK) concentration of two times the upper limit of normal.
Patients with unstable angina will be registered after 2011.
Management information
Registered date
| 2010 | Year | 11 | Month | 17 | Day |
Last modified on
| 2010 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005464
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
