UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024324 |
|---|---|
| Receipt number | R000028003 |
| Scientific Title | Comparative study of routine MRI sequences for the diagnosis of cerebral venous sinus thrombosis |
| Date of disclosure of the study information | 2016/10/07 |
| Last modified on | 2019/10/25 16:55:50 |
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Basic information
Public title
Comparative study of routine MRI sequences for the diagnosis of cerebral venous sinus thrombosis
Acronym
The routine MRI for CVST
Scientific Title
Comparative study of routine MRI sequences for the diagnosis of cerebral venous sinus thrombosis
Scientific Title:Acronym
The routine MRI for CVST
Region
| Japan |
Condition
Condition
Cerebral venous sinus thrombosis
Classification by specialty
| Neurology | Radiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate optimal MRI findings for diagnosing CVT with highest accuracy and investigate optimal combination of MRI findings for diagnosing CVT
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase IV
Assessment
Primary outcomes
Diagnostic performance of CVT by specific MRI findings:
Sensitivity and Specificity of optimal MRI findings
Key secondary outcomes
Diagnostic performance of combination of MRI findings:
Detection rate, Odds ratio, 95 % CI
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
Case group:
1.Patients who received routine MRI(T1WI, T2WI, FLAIR, DWI) within 14 days after symptom onset
2.Patients who diagnosed CVT in DSA, contrast 3D CTV, contrast MRV(venous phase of dynamic contrast MRA)
3.Confirmed diagnosis is performed within 7days from MRI exam.
4.Adult (20 years old or older)
5.regardless of gender
Control group:
1.Nothing abnormalities of cerebral venous sinus by routine MRI and DSA.
2.Patients who received routine MRI and DSA within 1 month
3.Normal clotting function (blood test)
4.Patients who eliminated from CVT in DSA
5.Adult (20 years old or older)
Key exclusion criteria
1.Patients with bleeding, edema or infarction involves brain hernia
2.Brain trauma (involve post operation) patient
3.Patient who have only cortical vein thrombosis or deep vein thrombosis.
4.Any others judged ineligible as a subject by the investigator
Target sample size
480
Research contact person
Name of lead principal investigator
| 1st name | Toshinori |
| Middle name | |
| Last name | HIRAI |
Organization
University of Miyazaki
Division name
Department of Radiology, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985852807
toshinorh@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshinori |
| Middle name | |
| Last name | HIRAI |
Organization
University of Miyazaki
Division name
Department of Radiology, Faculty of Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki
TEL
0985852807
Homepage URL
toshinorh@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Bayer Yakuhin, Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki
Address
Miyazaki
Tel
+81985852807
toshinorh@med.miyazaki-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
宮崎大学
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 07 | 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
310
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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
480 cases:
120 CVST cases, 360 controls
Management information
Registered date
| 2016 | Year | 10 | Month | 06 | Day |
Last modified on
| 2019 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028003
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
