UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
Registered date File name

Research case data
Registered date File name


Contact us.