UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048132 |
|---|---|
| Receipt number | R000054850 |
| Scientific Title | Systematic Multicenter study of unruptured cerebral Aneurysms based on Rheological Technique analysis at Mie |
| Date of disclosure of the study information | 2022/06/23 |
| Last modified on | 2022/06/22 12:15:19 |
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Basic information
Public title
Systematic Multicenter study of unruptured cerebral Aneurysms based on Rheological Technique analysis at Mie
Acronym
SMART Mie
Scientific Title
Systematic Multicenter study of unruptured cerebral Aneurysms based on Rheological Technique analysis at Mie
Scientific Title:Acronym
SMART Mie
Region
| Japan |
Condition
Condition
unruptured cerebral aneurysms
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the association between hemodynamic factors and subsequent growth or rupture of unruptured cerebral aneurysms by conducting a prospective observational study after hemodynamic analysis of all patients with unruptured cerebral aneurysms enrolled in a cooperative research center in Mie Prefecture.
Basic objectives2
Others
Basic objectives -Others
We will conduct a multicenter prospective observational study of all enrolled patients with unruptured cerebral aneurysms to examine hemodynamic factors and the effects of aneurysm growth, rupture, and treatment. The purpose of this study is to provide new evidence on the relationship between unruptured cerebral aneurysms and hemodynamic factors to the world.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ruptures of cerebral aneurysms
Key secondary outcomes
Aneurysmal growth greater than 0.5 mm
Obvious changes in shape
Surgical treatment of cerebral aneurysms to prevent rupture
Re-treatment after surgical treatment
Other deaths
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
1. Intracranial unruptured saccular cerebral aneurysm with a maximum diameter of 3 mm or greater
2. Cerebral aneurysms for which 3DCTA or PCMR imaging necessary for hemodynamic analysis can be performed around 1 month after enrollment
3. Consent to research with fully informed consent
4. Be at least 20 years of age on the date of consent to participate in this study
5. Independent in daily living (modified Rankin Scale 0~2)
6. Ability to make outpatient visits and follow-up observations
Key exclusion criteria
1. dissecting aneurysm, fusiform aneurysm, extracranial aneurysm
2. Patients with renal insufficiency not suitable for contrast enhanced examination, and who are not suitable for MR examination
3. Other patients deemed ineligible by the principal investigator or subinvestigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Suzuki |
| Middle name | |
| Last name | Hidenori |
Organization
Mie University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
mie1192suzuki@gmail.com
Public contact
Name of contact person
| 1st name | Yasuda |
| Middle name | |
| Last name | Ryuta |
Organization
Mie University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
TEL
059-232-1111
Homepage URL
yasudar1@gmail.com
Sponsor or person
Institute
Mie University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kuwana City Medical Center
Mie Prefectural General Medical Center
Suzuka Kaisei Hospital
Suzuka Chuo General Hospital
Mie Chuo Medical Center
Matsusaka Chuo General Hospital
Saiseikai Matsusaka General Hospital
Matsusaka Municipal Hospital
Japanese Red Cross Ise Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Ethics Review Committee of Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie 514-8507, Japan
Tel
059-231-5045
kk-sien@mo.medic.mie-u.ac.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
三重大学大学院医学系研究科（三重県）
桑名市総合医療センター（三重県）
三重県立総合医療センター（三重県）
鈴鹿回生病院（三重県）
鈴鹿中央総合病院（三重県）
三重中央医療センター（三重県）
松阪中央総合病院（三重県）
済生会松阪総合病院（三重県）
松阪市民病院（三重県）
伊勢赤十字病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 06 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 12 | Month | 21 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research Design Multicenter, prospective observational study
Basic data registration items at registration
1. Age, Sex, Ethnicity, Closed Age
2. Past History
3. Lifestyle Drinking and smoking
4. Family history of subarachnoid hemorrhage
5. Self sufficiency in daily life Modified Rankin Scale
6. Take medicine
7. Examination findings 3DCTA or MRA of head, blood sampling
8. Treatment presented to the patient by his/her physician
9. Treatment actually selected
Hemodynamic Analysis
Using anonymized 3DCTA or PCMR DICOM data, an independent analysis center performs the analysis by
follow up survey
Treatment of cerebral aneurysms is performed according to the usual policy based on stroke guidelines, and either observation or surgical treatment (craniotomy or endovascular treatment) is decided after consultation with the attending physician and patient as appropriate.
Management information
Registered date
| 2022 | Year | 06 | Month | 22 | Day |
Last modified on
| 2022 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054850
| 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 |
