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The Role of Cerebral Hemodynamics in Moyamoya Disease

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2015 by Washington University School of Medicine.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00629915
First Posted: March 6, 2008
Last Update Posted: June 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Washington University School of Medicine
  Purpose
The purpose of this study is to determine if people with moyamoya disease who have insufficient blood flow are at a higher risk for stroke.

Condition
Moyamoya Stroke

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Cerebral Hemodynamics in Moyamoya Disease

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Primary endpoint: ipsilateral ischemic stroke. [ Time Frame: 6 month intervals for up to 5 years after enrollment ]

Secondary Outcome Measures:
  • Stroke specific quality of life (SSQOL), modified Rankin Scale, Barthel index [ Time Frame: 6 month intervals for up to 5 years after enrollment ]
  • any stroke or death [ Time Frame: 6 month intervals for up to 5 years after enrollment ]

Enrollment: 56
Study Start Date: October 2006
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Detailed Description:

Moyamoya disease is a rare medical disorder that affects the blood vessels (pipes that transport blood) in the brain. In Moyamoya disease, the large blood vessels in the middle of the brain close down over time. The cause of this disorder is unknown. In order to compensate for this narrowing, the body grows new small blood vessels around the blockage. These small branches grow larger (and may be more numerous) to give the disorder its name. "Moyamoya" is the Japanese term for "puff of smoke" and is used to describe the hazy appearance of these small blood vessels on an angiogram.

Treatment for moyamoya is difficult because so little is known about the disease. Some people never have a stroke while others may have several. It is likely that the strokes are due to insufficient blood flow to the brain. There are surgical procedures that may improve blood flow to the brain, however, these procedures may cause complications and may not always improve the blood flow.

The main purpose of this study is to determine if people with moyamoya disease who have insufficient blood flow are at a higher risk for stroke. In this study researchers will learn more about the risks and potential benefits of surgical treatment. This information will help decide if there are people at higher risk for stroke who might benefit from surgery or if there are those at a lower risk who might not benefit.

In this study, participants will undergo baseline clinical and laboratory evaluation. Measurements of blood flow to the brain and oxygen use will be obtained using by positron emission tomography (PET). Participants will be followed for up to 5 years. PET studies will be conducted one and three years after enrollment to determine if blood flow improves over time. Participants treated with surgery (at the discretion of their treating physicians) will also be followed for perioperative complications, improvement in blood flow, and long term risk of stroke.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Persons with moyamoya disease will be recruited without restriction in regards to gender, race, age, and socioeconomic status. At Washington University, persons will be identified and recruited from the Neurosurgery service, the Stroke service of the Department of Neurology, and the Interventional Neuroradiology service.

We have invited several established stroke investigators at large tertiary care facilities in the Midwest to form a cooperative study group. All these investigators have large-volume clinical practices and see several people with moya moya disease each year.

Criteria

Inclusion Criteria:

  • Adult > 18 years of age
  • Capable of informed consent
  • Clinical: Both asymptomatic and symptomatic patients will be included.
  • Anatomic: Unilateral or bilateral imaging findings consistent with moyamoya collaterals (Suzuki stages 3 and 4) on digital subtraction, computed tomographic, or magnetic resonance angiography (after Suzuki and Kodama, 1983)

Exclusion Criteria:

  • Any other disease that might be responsible for the vasculopathy, including atherosclerosis, neurofibromatosis, meningitis, sickle cell disease, skull base radiation therapy.
  • Pregnancy: All women of child-bearing potential will be tested for pregnancy on the day of the enrollment and throughout the course of the study.
  • Surgery: Prior open or endovascular revascularization procedures, unless there have been ischemic symptoms since surgery and angiographic evidence that the procedure was not successful
  Contacts and Locations
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): NCT00629915


Locations
United States, Missouri
Washington University School Of Medicine, 510 South Kingshighway Blvd
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Colin Derdeyn, MD Washington University School of Medicine
  More Information

Publications:

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00629915     History of Changes
Other Study ID Numbers: R01NS051631 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2008
First Posted: March 6, 2008
Last Update Posted: June 3, 2015
Last Verified: June 2015

Keywords provided by Washington University School of Medicine:
Moyamoya
stroke

Additional relevant MeSH terms:
Cerebral Arterial Diseases
Moyamoya Disease
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases