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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical intervention | Active Comparator | All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery. |
|
| Conservative management(medical management) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extracranial-intracranial bypass surgery | Procedure | All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS) |
| Measure | Description | Time Frame |
|---|---|---|
| All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards | The number of participants who suffer from all strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards within 5 years of randomization | within 5 years of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| All kinds of adverse events related to surgery | The number of participants who suffer from all kinds of adverse events related to surgery within 30 days | up to 30 days |
| Rebleeding on the contralateral side |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuxiang Gu, MD,PhD | Department of Neurosurgery,Huashan Hospital,Fudan University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery,Huashan Hospital,Fudan University | Shanghai | 200040 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24668203 | Background | Miyamoto S, Yoshimoto T, Hashimoto N, Okada Y, Tsuji I, Tominaga T, Nakagawara J, Takahashi JC; JAM Trial Investigators. Effects of extracranial-intracranial bypass for patients with hemorrhagic moyamoya disease: results of the Japan Adult Moyamoya Trial. Stroke. 2014 May;45(5):1415-21. doi: 10.1161/STROKEAHA.113.004386. Epub 2014 Mar 25. | |
| 24668205 |
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| ID | Term |
|---|---|
| D009072 | Moyamoya Disease |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D002548 | Cerebral Revascularization |
| ID | Term |
|---|---|
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization
| up to 5 years |
| Transient ischemic attack on the surgically treated side | The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization | up to 5 years |
| The changes from baseline in modified Rankin Scale (mRS) | The changes from baseline in modified Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial | at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial |
| The changes from baseline in National Institute of Health Stroke Scale (NIHSS) | The changes from baseline in National Institute of Health Stroke Scale (NIHSS) at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial | at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial |
| The changes from baseline in modified Barthel Index | The changes from baseline in modified Barthel Index at 7 days, 30 days, 6 months, 12 months, 24 months，36 months，60 months or end of trial | at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial |
| Derdeyn CP. Direct bypass reduces the risk of recurrent hemorrhage in moyamoya syndrome, but effect on functional outcome is less certain. Stroke. 2014 May;45(5):1245-6. doi: 10.1161/STROKEAHA.114.004994. Epub 2014 Mar 25. No abstract available. |
| 19297575 | Background | Scott RM, Smith ER. Moyamoya disease and moyamoya syndrome. N Engl J Med. 2009 Mar 19;360(12):1226-37. doi: 10.1056/NEJMra0804622. No abstract available. |
| 11117870 | Background | Kobayashi E, Saeki N, Oishi H, Hirai S, Yamaura A. Long-term natural history of hemorrhagic moyamoya disease in 42 patients. J Neurosurg. 2000 Dec;93(6):976-80. doi: 10.3171/jns.2000.93.6.0976. |
| D009422 | Nervous System Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D008866 | Microsurgery |