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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001895
Receipt No. R000002290
Scientific Title Effect of EC-IC bypass surgery in the acute stage of atherothrombotic infarction in the territory of the carotid artery; a randomized clinical trial
Date of disclosure of the study information 2009/05/01
Last modified on 2014/04/21

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Basic information
Public title Effect of EC-IC bypass surgery in the acute stage of atherothrombotic infarction in the territory of the carotid artery; a randomized clinical trial
Acronym Acute bypass study
Scientific Title Effect of EC-IC bypass surgery in the acute stage of atherothrombotic infarction in the territory of the carotid artery; a randomized clinical trial
Scientific Title:Acronym Acute bypass study
Region
Japan

Condition
Condition Cerebral infarction
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of EC-IC bypass surgery in pateints in the acute stage of atherothrombotic cerebral infarction in the territory of carotid artery who demonstrate diffusio/perfusion mismatch and progressive deteriolation against full medical treatments.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Proportion of mRS 0-2 (good outcome) at 3 month after the second registration.
*patients who were in the waiting group and finally operated will be counted as bad outcome regardless of mRS at 3 month
Key secondary outcomes Effectiveness
a) Proportion of mRS 0-2 (good outcome) at 1 month after the second registration.
*patients who were in the waiting group and finally operated will be counted as bad outcome regardless of mRS at 1 month
b) Proportion of mRS 0-1 at 3 month after the second registration. *patients who were in the waiting group and finally operated will be counted as bad outcome regardless of mRS at 3 month
c) Proportion of patients with enlargement or recurrence of ipsilateral infarction within 1 month after the second registration. *patients who were in the waiting group and finally operated will be counted as enlargement regardless of imaging findings.
d) Evaluation of mRS at 3 month after the first registration in patients who were not included in the second registration; comparison between patients enrolled by using criteria of diffusion/perfusion mismatch and clinical/diffusion mismatch.
Safety
a) Rate of general complications which required elongation of hospital stay.*patients who were in the waiting group and finally operated will also be evaluated.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Bypass surgery immediately following second step of the registration
Interventions/Control_2 Medical therapy following second step of the registration. If there is a further aggravation by 3 points in NIHSS, bypass surgery will be proposed to the patient.
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
75 years-old >=
Gender Male and Female
Key inclusion criteria First step:1)age 20-75, 2)within 72 hours after the onset, 3) independent before the onset, 4) DWI-ASPECTS>or=8 and presence of diffusion/perfusion mismatch or clinical/diffusion mismatch.
Second step: Neurological deteriolation by 1-3 points in NIHSS scale (due to aggravetion of infarction or penumbra, but not edema or hemorrhagic infarction) following the first step. The vascular lesion must be out of indication of endovascular surgery or carotid endarterectomy.
Key exclusion criteria First step:1)preexisting ipsilateral cerebral infarction larger than 1/3 of the hemisphere, 2)candidates for endovascular surgery or carotid endarterectomy, 3) non-atherothrombotic lesion or cardioembolic infarction, 4) Association of severe general condition such as malignant tumors, renal/cardiac/liver/lung failure etc., 5) acute myocardial infarction within 6 months, 6) severe arythmia or ischemic changes on electrocardiogram.
Second step: 1) edema or hemorhagic infarction that can acount for the clinical deteriolation, 2) aggravation in the general condition
Target sample size 80

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, Aoba-ku, Sendai, 980-8574, Japan
TEL 022-717-7230
Email tomi@nsg.med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Shimizu
Organization Akita University Graduate School of Medicine
Division name Department of Neurosurgery
Zip code
Address 1-1-1, Hondo, Akita, 010-8543, Japan
TEL 018-884-6140
Homepage URL
Email hshim@nsg.med.akita-u.ac.jp

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 東北大学病院(宮城県) 広南病院(宮城県)仙台医療センター(宮城県)他

Other administrative information
Date of disclosure of the study information
2009 Year 05 Month 01 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
The study has been terminated because recruited patients were fewer than those expected.
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 Terminated
Date of protocol fixation
2009 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 10 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2013 Year 05 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 04 Month 18 Day
Last modified on
2014 Year 04 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002290

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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