UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025003 |
|---|---|
| Receipt number | 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 10:34:08 |
* 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
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
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
otahide@gmail.com
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028752
