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The Adult Hemorrhagic Moyamoya Surgery Study (AHMSS)

Primary Purpose

Moyamoya, Stroke

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Extracranial-intracranial bypass surgery
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moyamoya

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Neurosurgery,Huashan Hospital,Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Surgical intervention

Conservative management(medical management)

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Rebleeding on the contralateral side
The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization
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
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
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
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

Full Information

First Posted
November 28, 2014
Last Updated
February 13, 2016
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02319980
Brief Title
The Adult Hemorrhagic Moyamoya Surgery Study
Acronym
AHMSS
Official Title
The Adult Hemorrhagic Moyamoya Surgery Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moyamoya, Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical intervention
Arm Type
Active Comparator
Arm Description
All participants in this group will be assigned to receive extracranial-intracranial arterial bypass surgery.
Arm Title
Conservative management(medical management)
Arm Type
No Intervention
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Extracranial-intracranial bypass surgery
Other Intervention Name(s)
STA-MCA Bypass and EDMS
Intervention Description
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)
Primary Outcome Measure Information:
Title
All strokes & death within 30 days post-surgery and ipsilateral recurrent bleeding afterwards
Description
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
Time Frame
within 5 years of randomization
Secondary Outcome Measure Information:
Title
All kinds of adverse events related to surgery
Description
The number of participants who suffer from all kinds of adverse events related to surgery within 30 days
Time Frame
up to 30 days
Title
Rebleeding on the contralateral side
Description
The number of participants who suffer from rebleeding on the contralateral side within 5 years of randomization
Time Frame
up to 5 years
Title
Transient ischemic attack on the surgically treated side
Description
The number of participants who suffer from TIA on the surgically treated side within 5 years of randomization
Time Frame
up to 5 years
Title
The changes from baseline in modified Rankin Scale (mRS)
Description
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
Time Frame
at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial
Title
The changes from baseline in National Institute of Health Stroke Scale (NIHSS)
Description
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
Time Frame
at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial
Title
The changes from baseline in modified Barthel Index
Description
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
Time Frame
at 7 days, 30 days, 6 months, 12 months, 24 months, 36 months, 60 months or end of trial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Independent in activity of daily living(The modified Rankin Scale 0-2) At least one month since the most recent hemorrhagic stroke The neurological deficit must be stable for more than 6 weeks Bleeding in ventricle,cortex,basal ganglia,thalamus and subarachnoid space confirmed by computed tomography plain scan 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 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 Digital substraction angiography demonstrating the vasculopathy appeared unilaterally or bilaterally Competent to give informed consent Accessible and reliable for follow-up Exclusion Criteria: Other cerebrovascular diseases(such as intracranial aneurysm or brain arteriovenous malformation) probably causing intracranial hemorrhage Not independent in activity of daily living(The modified Rankin Scale 3-5) Moyamoya syndrome concomitant with other hereditary or autoimmune diseases(Grave's Disease,Type I Diabetes Mellitus,Type I Neurofibromatosis et al) Moyamoya disease with ruptured aneurysms located in the main stem of Willis' Circle Emergent evacuation of intracerebral hematoma damaging superficial temporal artery or cortical artery Emergent decompressive craniotomy causing automatically developed indirect revascularization Good collateral networks formed by spontaneous anastomosis between extracranial and intracranial vessels before surgery Life expectancy<1 years Pregnancy Unstable angina or myocardial infarction with recent 6 months Blood coagulation dysfunction Allergic to iodine contrast agent Abnormal liver function(alanine transaminase(ALT) and/or aspartate aminotransferase(AST)>3 times of normal range) Serum creatinine >3mg/dl Poorly controlled hypertension(systolic BP>160 mmHg,diastolic BP>100 mmHg) Poor glucose control(fasting blood glucose>16.7mmol/l) Concurrent participation in any other interventional clinical trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuxiang Gu, MD,PhD
Organizational Affiliation
Department of Neurosurgery,Huashan Hospital,Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Neurosurgery,Huashan Hospital,Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
24668203
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.
Results Reference
background
PubMed Identifier
24668205
Citation
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.
Results Reference
background
PubMed Identifier
19297575
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. No abstract available.
Results Reference
background
PubMed Identifier
11117870
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. doi: 10.3171/jns.2000.93.6.0976.
Results Reference
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The Adult Hemorrhagic Moyamoya Surgery Study

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