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The Adult Hemorrhagic Moyamoya Surgery Study (AHMSS)

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ClinicalTrials.gov Identifier: NCT02319980
Recruitment Status : Active, not recruiting
First Posted : December 19, 2014
Last Update Posted : February 17, 2016
Sponsor:
Information provided by (Responsible Party):
Hanqiang Jiang,MD, Huashan Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Moyamoya Stroke Procedure: Extracranial-intracranial bypass surgery Phase 3

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Adult Hemorrhagic Moyamoya Surgery Study
Study Start Date : May 2015
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Surgical intervention
All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
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)
Other Name: STA-MCA Bypass and EDMS

No Intervention: Conservative management(medical management)
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.



Primary Outcome Measures :
  1. All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards [ Time Frame: within 5 years of randomization ]
    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


Secondary Outcome Measures :
  1. All kinds of adverse events related to surgery [ Time Frame: up to 30 days ]
    The number of participants who suffer from all kinds of adverse events related to surgery within 30 days

  2. Rebleeding on the contralateral side [ Time Frame: up to 5 years ]
    The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization

  3. Transient ischemic attack on the surgically treated side [ Time Frame: up to 5 years ]
    The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization

  4. The changes from baseline in modified Rankin Scale (mRS) [ Time Frame: 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 Rankin Scale (mRS) at 7 days, 30 days, 6 months, 12 months, 24 months,36 months,60 months or end of trial

  5. The changes from baseline in National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 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) at 7 days, 30 days, 6 months, 12 months, 24 months,36 months,60 months or end of trial

  6. The changes from baseline in modified Barthel Index [ Time Frame: 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 at 7 days, 30 days, 6 months, 12 months, 24 months,36 months,60 months or end of trial



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319980


Locations
China
Department of Neurosurgery,Huashan Hospital,Fudan University
Shanghai, China, 200040
Sponsors and Collaborators
Huashan Hospital
Investigators
Study Chair: Yuxiang Gu, MD,PhD Department of Neurosurgery,Huashan Hospital,Fudan University