The Role of Cerebral Hemodynamics in Moyamoya Disease
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Role of Cerebral Hemodynamics in Moyamoya Disease|
- Primary endpoint: ipsilateral ischemic stroke. [ Time Frame: 6 month intervals for up to 5 years after enrollment ] [ Designated as safety issue: No ]
- Stroke specific quality of life (SSQOL), modified Rankin Scale, Barthel index [ Time Frame: 6 month intervals for up to 5 years after enrollment ] [ Designated as safety issue: No ]
- any stroke or death [ Time Frame: 6 month intervals for up to 5 years after enrollment ] [ Designated as safety issue: No ]
|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)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629915
|United States, Missouri|
|Washington University School Of Medicine, 510 South Kingshighway Blvd|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Colin Derdeyn, MD||Washington University School of Medicine|