Moyamoya disease
Conditions
Interventions
EC-IC bypass on both sides (each side with some interval between). As the operative maneuver, the direct bypass procedures such as STA-MCA anastomosis are essential. A surgeon can add an indirect bypa
Sponsors
JAM Trial executive and steering committee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical requirements. (1) Age: between 16 and 65 at the time of the initial bleeding episode. (2) Independent in their daily lives :modified Rankin disability scale 0-2 or 3 (supplement trial). (3) Intracerebral hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage within the preceding 12 months (4) At least one month should have passed after the last stroke episode, either ischemic or hemorrhagic. (5) At least one month should have passed after the completion of acute phase treatment for the hemorrhages and for the related secondary pathophysiology (e.g. hydrocephalus) . 2. Radiological requirements (1) CT/MRI (a) Lack of large infarction which widely spreads over the territory of a main arterial trunk. (b) Lack of contrast enhancement in the infracted area (2) Angiography (a) Angiographic findings should satisfy the diagnostic criteria of the spontaneous occlusion of the Circle of Willis (Moyamoya disease) published by the Ministry of Health, Labor and Welfare of Japan (b) No aneurysms are detected in major cerebral arteries.
Exclusion criteria
Exclusion criteria: (1) Not independent in daily lives (2) Atherosclerotic carotid disease, or cardiac arrhythmia which may cause thromboembolic complications (3) Malignant tumors or organ failure of the heart, liver, kidney, or lung (4) Unstable angina or has had a myocardial infarction within the past 6 months (5) Hematological abnormality showing bleeding diathesis (6) Uncontrolled diabetes showing a serum fasting blood glucose level of more than 300mg/dl, or requires insulin (7) Hypertension with the diastolic blood pressure of more than 110mmHg (8) Treated with EC-IC bypass surgery before enrollment (9) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) recurrent bleeding (2) completed stroke causing significant morbidity in daily life activities (3) significant morbidity or mortality from other causes (4) the additional performance of EC-IC bypass by the decision of the participating neurologist such as in cases with progressive stroke, or crescendo TIA | — |
Secondary
| Measure | Time frame |
|---|---|
| The following events which occurs 3 months after enrollment: (1) recurrent bleeding on the same side of the previous bleeding (2) hemorrhage-related death or severe disability | — |
Countries
Japan
Contacts
Public ContactSusumu Miyamoto
National Cardiovascular Center Department of Neurosurgery, JAM Trial Office
Outcome results
None listed