UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030983 |
|---|---|
| Receipt number | R000035167 |
| Scientific Title | epidemiologic research about prognosis of Abdominal aortic aneurysm and iliac artery aneurysm Patients. |
| Date of disclosure of the study information | 2018/01/24 |
| Last modified on | 2018/01/24 22:48:49 |
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Basic information
Public title
epidemiologic research about prognosis of Abdominal aortic aneurysm and iliac artery aneurysm Patients.
Acronym
epidemiologic research about prognosis of AAA and IAA patients.
Scientific Title
epidemiologic research about prognosis of Abdominal aortic aneurysm and iliac artery aneurysm Patients.
Scientific Title:Acronym
epidemiologic research about prognosis of AAA and IAA patients.
Region
| Japan |
Condition
Condition
Abdominal Aortic Aneurysm (AAA)
Iliac Artery Aneurysm (IAA)
Classification by specialty
| Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the appropriate follow up and surgical indication in the AAA and IAA patients in Asia by investigating the prognosis of them either after surgery or in natural course prospectively. Furthermore, to find a clue of nonoperative therapy by detecting risk factors of Aneurysm expansion and rupture,
Basic objectives2
Others
Basic objectives -Others
prospective observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
over all survival
Key secondary outcomes
Aneurysm rupture
surgical complications
reinterventions for aneurysm
growth rate of aneurysm
Morbidity rate of atherosclerotic cardiocascular diseases
transitions of quality of life, activity of daily life and cognitive fuction
medical expenses
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
Preoperative AAA and/or IAA patients who receive a medical examination at Tohoku University Hospital or affiliated hospitals.
Patinets who understand this study and consent to join this study.
20 yeras of age or over.
Key exclusion criteria
Patines who do not consent to join this study.
Under 20 years of age.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Goto Hitoshi |
Organization
Tohoku University Hospital
Division name
Department of Transplantation, Reconstruction and Endoscopic Surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7214
h-goto@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tajima Yuta |
Organization
Tohoku University Hospital
Division name
Department of Transplantation, Reconstruction and Endoscopic Surgery
Zip code
Address
1-1 Seiryo-cho, Aoba-ku, Sendai 980-8574, Japan
TEL
022-717-7214
Homepage URL
yuta.tajima.a6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku Universiity
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 01 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Preinitiation
Management information
Registered date
| 2018 | Year | 01 | Month | 24 | Day |
Last modified on
| 2018 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035167
| Research Plan | |
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| 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 |
