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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025003
Receipt No. R000028752
Scientific Title Detection of pulsation in unruptured cerebral aneurysms by ECG-gated 3D-CT angiography (4D-CTA) and evaluation of its clinical usefulness
Date of disclosure of the study information 2016/11/26
Last modified on 2016/11/26

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Basic information
Public title Detection of pulsation in unruptured cerebral aneurysms by ECG-gated 3D-CT angiography (4D-CTA) and evaluation of its clinical usefulness
Acronym Detection of pulsation in unruptured cerebral aneurysms by ECG-gated 3D-CT angiography (4D-CTA)
Scientific Title Detection of pulsation in unruptured cerebral aneurysms by ECG-gated 3D-CT angiography (4D-CTA) and evaluation of its clinical usefulness
Scientific Title:Acronym Detection of pulsation in unruptured cerebral aneurysms by ECG-gated 3D-CT angiography (4D-CTA)
Region
Japan

Condition
Condition Intracranial unruptured aneurysms
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By ECG gated 3D-computed tomography angiography (4D-CTA), we detect pulsation in unruptured cerebral aneurysms. The clinical usefulness of this method is then evaluated.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Size, shape, location, and pulsation of Unruptured aneurysms are evaluated by 4D-CTA.
Then we follow the size of unruptured aneurysms by performing MRI or 3D-CTA, until August 2021.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 3D-CTA is performed to follow unruptured aneurysms in our hospital. We perform 4D-CTA insetad of 3D-CTA and evaluate pulsation of unruptured aneurysms under the agreement.
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 Intracranial unruptured aneurysms which aren't indication for surgery.
Key exclusion criteria Unruptured aneurysms which are indication for surgery, or have already been performed surgery.
Renal failure(EGFR<60 m/min/1.73 sqm)
Pregnant or lactating patients.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ota
Organization Tohoku University Hospital
Division name the Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL 022-717-7312
Email otahide@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Ota
Organization Tohoku University Hospital
Division name the Department of Diagnostic Radiology
Zip code
Address 1-1 Seiryo, Aoba, Sendai 980-8574, Japan
TEL 022-717-7312
Homepage URL
Email otahide@gmail.com

Sponsor
Institute Tohoku University
Institute
Department

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
Email

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 東北大学病院(宮城県)

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 26 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
2016 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 26 Day
Last modified on
2016 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028752

Research Plan
Registered date File name
2016/11/26 rinri.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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