UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001895 |
|---|---|
| Receipt number | 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 10:24:02 |
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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
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
hshim@nsg.med.akita-u.ac.jp
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
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002290
