UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014548 |
|---|---|
| Receipt number | R000016774 |
| Scientific Title | Clinical Reserch of Angiographic CT with Intravenous Contrast Injection |
| Date of disclosure of the study information | 2014/07/14 |
| Last modified on | 2016/07/17 14:22:49 |
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Basic information
Public title
Clinical Reserch of Angiographic CT with Intravenous Contrast Injection
Acronym
Clinical Reserchi of ivACT
Scientific Title
Clinical Reserch of Angiographic CT with Intravenous Contrast Injection
Scientific Title:Acronym
Clinical Reserchi of ivACT
Region
| Japan |
Condition
Condition
Untreated unruptured cerebral aneurysms, untreated stenosis of intracranial arteries, clipped cerebral aneurysms, coiled cerebral aneurysms, stented intracranial arteries
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of angiographic CT with intravenous contrast injection (ivACT) compared with CT angiography (CTA) or MR angiography (MRA).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Various measured values and image quality
Key secondary outcomes
Radiocontrast-induced deterioration in renal function
Allergic reaction to contrast agent
Other adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
angiographic CT with intravenous contrast injection
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) Patients scheduled for CT angiography of untreated unruptured cerebral aneurysm
2) Patients scheduled for CT angiography of untreated intracranial arterial stenosis
3) Patients scheduled for CT angiography of clipped cerebral aneurysm
4) Patients scheduled for MR angiography of coiled cerebral aneurysm
5) Patients scheduled for CT angiography of stented intracranial arterial stenosis
Key exclusion criteria
1) Patient of chronic kidney disease (estimated glomerular filtration rate < 60ml/min/1.73m2)
2) Patient with a history of allergic reaction to contrast agent
3) Pregnant patient or patient who may become pregnant
4) Lactating woman
5) Patient who cannot understand the explanation of study or express one's consent due to impaired consciousness or dementia
6) Patient who is judged as inadequate for the study by responsible person or other members of study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohito Hishikawa |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Departement of Neurological Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7336
t-hishi@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Hiramatsu |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Departement of Neurological Surgery
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7336
Homepage URL
tzigane_ravel@yahoo.co.jp
Sponsor or person
Institute
Departement of Neurological Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
The Japanese Society for Neuroendovascular Therapy
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 10 | 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
| 2014 | Year | 07 | Month | 14 | Day |
Last modified on
| 2016 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016774
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
