UMIN-CTR Clinical Trial

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
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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
Email	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
Email	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
Email	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
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
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Research case data
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