UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034196 |
|---|---|
| Receipt number | R000038984 |
| Scientific Title | Evaluation of Blood Thrombogenicity in Acute Myocardial Infarction (EBTAMI) Study |
| Date of disclosure of the study information | 2018/09/19 |
| Last modified on | 2019/04/08 16:04:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of Blood Thrombogenicity in Acute Myocardial Infarction (EBTAMI) Study
Acronym
EBTAMI Study
Scientific Title
Evaluation of Blood Thrombogenicity in Acute Myocardial Infarction (EBTAMI) Study
Scientific Title:Acronym
EBTAMI Study
Region
| Japan |
Condition
Condition
Prospective observational study
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the mechanism of acute coronary syndrome onset, measure the blood thrombogenicity in acute MI, unstable angina, and stable coronary artery disease patients.
Basic objectives2
Others
Basic objectives -Others
pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood thrombogenicity measured by T-TAS
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
acute myocardial infarction, unstable angina, or stable coronary artery disease patients
Key exclusion criteria
none
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yasunori |
| Middle name | |
| Last name | Ueda |
Organization
National Hospital Organization, Osaka National Hospital
Division name
Cardiovascular Division
Zip code
540-0006
Address
2-1-14 Hoenzaka, Chuo-ku
TEL
+81669421331
ueda@onh.go.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Ueda |
Organization
National Hospital Organization, Osaka National Hospital
Division name
Cardiovascular Division
Zip code
540-0006
Address
2-1-14 Hoenzaka
TEL
+81669421331
Homepage URL
ueda@onh.go.jp
Sponsor or person
Institute
National Hospital Organization, Osaka National Hospital
Institute
Department
Personal name
Funding Source
Organization
Pfizer, Bayer, Daiichi-Sankyo, Astellas, Shionogi, Nihon Kohden, Abbott vascular
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka National Hospital Institutional Review Board #2
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka, OSAKA 540-0006, JAPAN
Tel
+81-6-6942-1331
chiken@onh.go.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
| 2018 | Year | 09 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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 blood thrombogenicity will be measured by T-TAS in acute myocardial infarction, unstable angina and stable coronary artery disease patients.
Management information
Registered date
| 2018 | Year | 09 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038984
