UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004557 |
|---|---|
| Receipt number | 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 | 2021/05/23 09:52:20 |
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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 | Teiji |
| Middle name | |
| Last name | Tominaga |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
TEL
022-717-7230
teijitmng@gmail.com
Public contact
Name of contact person
| 1st name | Hidenori |
| Middle name | |
| Last name | Endo |
Organization
Kohnan hospital
Division name
Neurosurgery
Zip code
982-8523
Address
4-20-1 Nagamachi-minami, Taihaku-ku, Sendai, 982-8523, Japan
TEL
022-248-2131
Homepage URL
hideendo@gmail.com
Sponsor or person
Institute
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
IRB of Tohoku University
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
Tel
022-718-0461
office@nrs.hosp.tohoku.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
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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2010 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 04 | Month | 30 | Day |
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
| 2021 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005039
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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