Effect of EC-IC bypass surgery in the acute stage of atherothrombotic infarction in the territory of the carotid artery; a randomized clinical trial

UMIN ID: UMIN000001895

Registered date:01/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Cerebral infarction
• Date of first enrollment: 2009/05/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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 will be proposed to the patient.

Outcome(s)

• Primary Outcome: 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 Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Neurosurgery, Tohoku University Graduate School of Medicine
• Source(s) of Monetary Support: Department of Neurosurgery, Tohoku University Graduate School of Medicine