Overview

This trial is active, not recruiting.

Conditions moyamoya, stroke
Sponsor Washington University School of Medicine
Collaborator National Institute of Neurological Disorders and Stroke (NINDS)
Start date October 2006
End date June 2017
Trial size 56 participants
Trial identifier NCT00629915, R01NS051631

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

Primary Outcomes

Measure
Primary endpoint: ipsilateral ischemic stroke.
time frame: 6 month intervals for up to 5 years after enrollment

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The Role of Cerebral Hemodynamics in Moyamoya Disease
Principal investigator Colin Derdeyn, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.