The Adult Hemorrhagic Moyamoya Surgery Study

Stroke Clinical Trial

— AHMSS  

Official title:

The Adult Hemorrhagic Moyamoya Surgery Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02319980
• Other study ID #: CAHMD 2014
• Status: Active, not recruiting
• Phase: Phase 3
• First received: November 28, 2014
• Last updated: February 13, 2016
• Start date: May 2015
• Est. completion date: May 2023

Study information

• Verified date: February 2016
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moyamoya
• Moyamoya Disease
• Stroke

Intervention

Procedure:
• Extracranial-intracranial bypass surgery
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)

Locations

Country	Name	City	State
China	Department of Neurosurgery,Huashan Hospital,Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

Scott RM, Smith ER. Moyamoya disease and moyamoya syndrome. N Engl J Med. 2009 Mar 19;360(12):1226-37. doi: 10.1056/NEJMra0804622. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	Rebleeding on the contralateral side	The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization	up to 5 years	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No