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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000048132 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | unruptured cerebral aneurysms | |
Classification by specialty |
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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 | |
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Randomization | |
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Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Interventions/Control_1 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 1000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Mie University Graduate School of Medicine |
Institute | |
Department |
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 |
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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 | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054850 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |