UMIN-CTR Clinical Trial

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
Email	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
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	IRB of Tohoku University
Address	1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, JAPAN
Tel	022-718-0461
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005039