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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000024324
Receipt No. 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 2018/10/12

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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
Middle name
Last name Toshinori HIRAI
Organization University of Miyazaki
Division name Department of Radiology, Faculty of Medicine
Zip code
Address 5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki 889-1692
TEL +81985852807
Email toshinorh@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshinori HIRAI
Organization University of Miyazaki
Division name Department of Radiology, Faculty of Medicine
Zip code
Address 5200 Kiyotakecho Kihara, Miyazaki-city, Miyazaki 889-1692
TEL +81985852807
Homepage URL
Email toshinorh@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

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
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

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
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
2016 Year 08 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 07 Day
Last follow-up date
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
2018 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028003

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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