Effect of Surgical Revascularization on Hemorrhagic Moyamoya Disease (ESRHMMD)

January 29, 2019 updated by: Affiliated Hospital to Academy of Military Medical Sciences

Effect of Surgical Revascularization and Conservative Treatment on Hemorrhagic Moyamoya Disease

Moyamoya Disease(MMD), also known as spontaneous basilar artery occlusion, is characterized by the gradual thickening of arterial intima at the distal carotid artery and the proximal portion of anterior/middle cerebral artery, the gradual stenosis or occlusion of arterial lumen, and the compensatory expansion of basilar cerebral perforating arteries. Cerebral infarction and cerebral hemorrhage are common clinical symptoms of MMD with high morbidity of disability. For ischemic moyamoya disease, intracranial/extracranial revascularization is the preferred treatment. However, for patients with hemorrhagic moyamoya disease, there is controversy about whether to have surgical treatment, the timing and the method of surgical treatment, and the effect of surgical treatment to prevent rebleeding due to the lack of large sample, multi-center, prospective randomized studies. At present, the studies on the effect of revascularization and conservative treatment on hemorrhagic moyamoya disease are retrospective case analyses without randomized control. The sample size of these studies are small, and the conclusions obtained are inconsistent. Due to the differences in the epidemiology and episode type of moyamoya disease in different countries, there is no prospective, randomized controlled study of blood type moyamoya disease in China to confirm the efficacy of revascularization and lack of uniform norms and standards.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Objective: The aim of this study is to perform a prospective, randomized study on hemorrhagic moyamoya disease to confirm the effect of revascularization in China, and to establish specifications and standards to guide the treatment options for hemorrhagic moyamoya disease as well.

Design: This study is a single-center study and plan to include 108 patients. According to a random number table, hemorrhagic moyamoya patients will be assigned to three groups: conservative treatment group, direct revascularization group and indirect revascularization group. A prospective, randomized study will be carried out to evaluate the effect of revascularization and conservative treatment on the reduction of rebleeding risk and improvement of ischemia in adult patients with hemorrhagic moyamoya disease.

Observation Measures: 1.Rebleeding; 2.Cerebral infarction resulting in severe disability (mRS score≥3); 3.Severe disability or death caused by other reasons; 4. Patients in conservative treatment group need revascularization due to progressive ischemic stroke or progressive Transient ischemic attack(TIA).

Study Type

Interventional

Enrollment (Anticipated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100071
        • Recruiting
        • The 307th Hospital of Military Chinese People's Liberation Army
        • Contact:
          • Lian Duan, Chief

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSA/MRA shows stenosis or occlusion in the distal internal carotid artery or the proximal portion of anterior/middle cerebral artery
  • Abnormal vascular network appeared in the brain
  • Lesions showed bilateral changes
  • Age≥18 years
  • With the onset of cerebral hemorrhage
  • No cerebral infarction or cerebral hemorrhage occurred within the last month
  • At least one month after the acute phase of cerebral hemorrhage or related diseases was treated

Exclusion Criteria:

  • Patients with moyamoya syndrome secondary to systemic diseases such as arteriosclerosis, sickle cell anemia, radiation therapy, etc..
  • Patients with severe mental disorders such as psychosis, liver and kidney dysfunction, poor blood pressure or blood glucose control, severe depression and substance abuse, low IQ, and acute phase of severe stroke with definite limb dysfunction should also be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Conservative treatment
Conservative treatment. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, the prevention and treatment of secondary epilepsy, the control of intracranial hypertension(including the application of mannitol and glycerol fructose, etc.), and the corresponding symptomatic and neurotrophic treatment. Non-specific treatment is mainly deal with intracranial hematoma, including intraventricular drainage, intracranial hematoma evacuation, and ventriculoperitoneal shunt.
Experimental: Indirect vascular reconstruction surgery
Indirect vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) is performed. The surgery is performed according to the procedures described by Matsushima.
Procedure: Conservative treatment
  1. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, prevention and treatment of secondary epilepsy, the control of intracranial hypertension, and the corresponding symptomatic and neurotrophic treatment.
  2. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) will be performed according to the procedures described by Matsushima.
  3. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) by pass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And the STA may not be preserved.
Other Names:
  • indirect revascularization
  • direct revascularization
Experimental: direct vascular reconstruction surgery
Direct vascular reconstruction surgery. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) bypass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And if necessary, the STA may not be preserved. The bone flap should be large enough to select the right recipient blood vessel.
Procedure: Conservative treatment
  1. The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, prevention and treatment of secondary epilepsy, the control of intracranial hypertension, and the corresponding symptomatic and neurotrophic treatment.
  2. In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) will be performed according to the procedures described by Matsushima.
  3. In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) by pass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And the STA may not be preserved.
Other Names:
  • indirect revascularization
  • direct revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rebleeding
Time Frame: Through study completion, an average of 1 year
All enrolled patients were followed up regularly by telephone, outpatient and inpatient visits. The observed end-point events of rebleeding
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe Disability
Time Frame: Through study completion, an average of 1 year
Cerebral infarction resulting in severe disability (mRS score≥3)
Through study completion, an average of 1 year
Severe Disability or Death
Time Frame: Through study completion, an average of 1 year
Severe disability or death caused by other reasons
Through study completion, an average of 1 year
Vascular Reconstruction due to Progressive Ischemic Stroke or Progressive TIA
Time Frame: Through study completion, an average of 1 year
Patients in conservative treatment group needs vascular reconstruction due to progressive ischemic stroke or progressive TIA.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Investigators

  • Study Chair: Lian Lian, Chief, The 307th Hospital of Military Chinese People's Liberation Army

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2017

Primary Completion (Anticipated)

October 1, 2020

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 29, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Z171100001017144

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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