UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001585 |
|---|---|
| Receipt number | R000001907 |
| Scientific Title | development of diagnostic marker kit for acute aortic dissection |
| Date of disclosure of the study information | 2009/01/01 |
| Last modified on | 2017/06/23 15:52:33 |
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Basic information
Public title
development of diagnostic marker kit for acute aortic dissection
Acronym
development of diagnostic marker kit for acute aortic dissection
Scientific Title
development of diagnostic marker kit for acute aortic dissection
Scientific Title:Acronym
development of diagnostic marker kit for acute aortic dissection
Region
| Japan |
Condition
Condition
acute aortic dissection
Classification by specialty
| Cardiology | Vascular surgery | Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study whether our original kit is useful for diagnosis of acute aortic dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positive predictive value
negative predictive value
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with suddenly occured chest or back pain.
And patients examined with CT or aortography to diagnose dissected aorta.
Key exclusion criteria
Acute myocardial infarction with ECG
Trauma
Patients who don't consent this study
Patients who are not examined with CT or aortography
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kurihara |
Organization
School of Medicine, Keio University
Division name
Emergency & Critical Care Medicine
Zip code
Address
03-3225-1323
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohiro Kurihara |
Organization
School of Medicine, Keio University
Division name
Emergency & Critical Care Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
School of Medicine, Keio University
Emergency & Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
DAIICHI FINE CHEMICAL CO.LTD.
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
| 2009 | 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
| 2008 | Year | 12 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We'll check the result of this diagnostic kit against the diagnosis of CT or aortography.
Management information
Registered date
| 2008 | Year | 12 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001907
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
