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| Sponsors and Collaborators: |
Washington University School of Medicine National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | National Institute of Neurological Disorders and Stroke (NINDS) |
| ClinicalTrials.gov Identifier: | NCT00629915 |
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: | Cohort, Prospective |
| Official Title: | The Role of Cerebral Hemodynamics in Moyamoya Disease |
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2006 |
| Estimated Study Completion Date: | October 2011 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nancy Hantler, CCRC | 314-362-9056 | nancy.hantler@wustl.edu |
| United States, Missouri | |
| Washington University School Of Medicine, 510 South Kingshighway Blvd | Recruiting |
| St. Louis, Missouri, United States, 63110 | |
| Contact: Nancy Hantler, CCRC 314-362-9056 nancy.hantler@wustl.edu | |
| Principal Investigator: Colin Derdeyn, MD | |
| Principal Investigator: | Colin Derdeyn, MD | Washington University School of Medicine |
More Information
| Responsible Party: | Washington University School of Medicine ( Colin Derdeyn, MD, Principal Investigator ) |
| Study ID Numbers: | R01NS051631, NP755 |
| Study First Received: | March 4, 2008 |
| Last Updated: | September 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00629915 |
| Health Authority: | United States: Federal Government |
|
Moyamoya stroke |
|
Arterial Occlusive Diseases Moyamoya disease 1 Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases |
Cerebral Arterial Diseases Brain Diseases Carotid Artery Diseases Intracranial Arterial Diseases Cerebrovascular Disorders Moyamoya Disease |
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Nervous System Diseases Cardiovascular Diseases |
