The Adult Hemorrhagic Moyamoya Surgery Study (AHMSS)

Fudan University

Status and phase: Unknown; Phase 3

Conditions: Stroke; Moyamoya

Treatments: Procedure: Extracranial-intracranial bypass surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT02319980

CAHMD 2014

Details and patient eligibility

About

The aim of this study is to investigate whether extracranial-intracranial(EC-IC) bypass surgery could prevent rebleeding and improve neurological function in adult moyamoya with hemorrhagic onset.

Full description

About one half of adult moyamoya patients present with hemorrhagic onset.As the bleeding events are potentially fatal, it often lead to particularly poor prognosis.However, the natural history is still poorly understood.Although the rebleeding rate is known to be extremely high,no effective therapeutic method has been established based on a worldwide consensus.

The recently published Japanese Adult Moyamoya(JAM) Trial, which is the first prospective,randomized,controlled trial focused on hemorrhagic moyamoya,showed that direct bypass surgery could reduce the rebleeding rate and improve the prognosis.However,the result was statistically marginal with a small sample size and most importantly,it failed to assess the neurological function.The effect of bypass surgery on functional outcome was uncertain.

Therefore,the AHMSS study in China is designed to compare the efficacy and safety of EC-IC bypass surgery with conservative treatment in adult moyamoya patients with hemorrhagic onset by comprehensive assessment of rebleeding rate, neurological function.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Independent in activity of daily living(The modified Rankin Scale 0-2)
2. At least one month since the most recent hemorrhagic stroke
3. The neurological deficit must be stable for more than 6 weeks
4. Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan
5. Digital substraction angiography demonstrating progressive stenosis or occlusion in the terminal portion of the internal carotid artery and/or the initial portion of the anterior or middle cerebral arteries
6. Digital substraction angiography demonstrating formation of abnormal collateral networks(moyamoya vessels) at the base of the brain,mainly in the region of thalamus and basal ganglia
7. Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally
8. Competent to give informed consent
9. Accessible and reliable for follow-up

Exclusion criteria

1. Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage
2. Not independent in activity of daily living(The modified Rankin Scale 3-5)
3. Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al)
4. Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle
5. Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery
6. Emergent decompressive craniotomy causing automatically developed indirect revascularization
7. Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery
8. Life expectancy<1 years
9. Pregnancy
10. Unstable angina or myocardial infarction with recent 6 months
11. Blood coagulation dysfunction
12. Allergic to iodine contrast agent
13. Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range)
14. Serum creatinine >3mg/dl
15. Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg)
16. Poor glucose control(fasting blood glucose>16.7mmol/l)
17. Concurrent participation in any other interventional clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 2 patient groups

Surgical intervention

Active Comparator group

Description:

All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.

Treatment:

Procedure: Extracranial-intracranial bypass surgery

Conservative management(medical management)

No Intervention group

Description:

All participants in this group will be assigned to receive conservative management or medical management which involves drug therapy as considered appropriate for medical symptoms by the treating investigator.