UMIN-CTR Clinical Trial

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
Email	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
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	University of Miyazaki
Address	Miyazaki
Tel	+81985852807
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028003