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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004557
Receipt No. R000005039
Scientific Title Natural history of vertebral artery dissection presented with non-hemorrhagic and non-ischemic sympotoms
Date of disclosure of the study information 2010/11/15
Last modified on 2015/06/02

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Basic information
Public title Natural history of vertebral artery dissection presented with non-hemorrhagic and non-ischemic sympotoms
Acronym Natural history of vertebral artery dissection (VAD study)
Scientific Title Natural history of vertebral artery dissection presented with non-hemorrhagic and non-ischemic sympotoms
Scientific Title:Acronym Natural history of vertebral artery dissection (VAD study)
Region
Japan

Condition
Condition Vertebral artery dissection
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the natural history of the vertebral artery dissection presented with non-hemorrhagic and non-ischemic symptoms
Basic objectives2 Others
Basic objectives -Others To clarify the percentage of the patients resulting in subarachnoid hemorrhage, cerebral infarction or radiographic progression, among those who initially presented with pain (acute headache or neck pain) as the only symptom of vertebral artery dissection
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Percentage of the patients resulting in subarachnoid hemorrhage, cerebral infarction or radiographic progression within 6 months after inclusion, among those who initially presented with pain (headache or neck pain) as the only symptom of vertebral artery dissection
Key secondary outcomes 1. Percentage of the vertebral artery dissection among those who present with acute headache or neck pain
2. Percentage of the onset of subarachnoid hemorrhage, cerebral infarction or radiographic progression within 6 months after inclusion
3. Percentage of the patients without any radiographical changes within 6 months after inclusion
4. Percentage of the patients with radiographical improvement within 6 months after inclusion
5. Modified Rankin scale of the patients 6 months after inclusion

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
80 years-old >=
Gender Male and Female
Key inclusion criteria (1) First inclusion criteria: Those who meet all the following criteria (A)-(C) are included.
(A) Those who meet (a), (b) and (c), or only (d)
(a) Presence of headache and/or neck pain. Laterality and characteristics of the pain are not considered
(b) Sudden onset
(c) Disturbance in daily living such as work, housework or school attendance, at least temporarily
(d) Admission by an ambulance car with complaint of acute headache and/or neck pain
(B) Within 24 hours after the onset
(C) Age between 20 and 80 years old.
(D) Informed consent available.
(2) Second inclusion criteria
(A) Vertebral artery dissection in MRI/MRA studies within 4 hours after initial presentation
(B) No subarachnoid hemorrhage or cerebral infarction associated with this presentation
Key exclusion criteria (a) One or more points in modified National Institutes of Health Stroke Scale (NIHSS)
(b) Subarachnoid hemorrhage, intracerebral hematoma or cerebral infarction
(c) Under antithrombotic treatment
(d) Previous open surgery or endovascular therapy for the posterior fossa or the neck
(e) Contraindication for magnetic resonance imaging
Target sample size 65

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Teiji Tominaga
Organization Tohoku University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL 022-717-7230
Email teijitmng@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Endo
Organization Kohnan hospital
Division name Neurosurgery
Zip code
Address 4-20-1 Nagamachi-minami, Taihaku-ku, Sendai, 982-8523, Japan
TEL 022-248-2131
Homepage URL
Email hideendo@gmail.com

Sponsor
Institute Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Tohoku University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 11 Month 15 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 Open public recruiting
Date of protocol fixation
2010 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The patients presented with sudden onset of headache and/or neck pain are included. MRI/MRA findings of these patients are regularly assessed. The goal of this study is to clarify the percentage of patients resulting in subarachnoid hemorrhage, cerebral infarction or radiographic progression within 6 months after inclusion.

Management information
Registered date
2010 Year 11 Month 15 Day
Last modified on
2015 Year 06 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005039

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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