Cerebral infarction
Conditions
Interventions
Bypass surgery immediately following second step of the registration
Medical therapy following second step of the registration. If there is a further aggravation by 3 points in NIHSS, bypass surgery w
Sponsors
Department of Neurosurgery, Tohoku University Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactHiroaki Shimizu
Akita University Graduate School of Medicine Department of Neurosurgery
Outcome results
None listed