The Role of Cerebral Hemodynamics in Moyamoya Disease

Stroke Clinical Trial

Official title:

The Role of Cerebral Hemodynamics in Moyamoya Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629915
• Other study ID #: 201103026
• Secondary ID: R01NS051631
• Status: Completed
• Start date: October 2006
• Est. completion date: June 2015

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Moyamoya
• Moyamoya Disease
• Stroke

Locations

Country	Name	City	State
United States	Washington University School Of Medicine, 510 South Kingshighway Blvd	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Arias EJ, Derdeyn CP, Dacey RG Jr, Zipfel GJ. Advances and surgical considerations in the treatment of moyamoya disease. Neurosurgery. 2014 Feb;74 Suppl 1:S116-25. doi: 10.1227/NEU.0000000000000229. Review. — View Citation

Ashley WW Jr, Zipfel GJ, Moran CJ, Zheng J, Derdeyn CP. Moyamoya phenomenon secondary to intracranial atherosclerotic disease: diagnosis by 3T magnetic resonance imaging. J Neuroimaging. 2009 Oct;19(4):381-4. doi: 10.1111/j.1552-6569.2008.00272.x. — View Citation

Goyal MS, Hallemeier CL, Zipfel GJ, Rich KM, Grubb RL Jr, Chicoine MR, Moran CJ, Cross DT 3rd, Dacey RG Jr, Derdeyn CP. Clinical features and outcome in North American adults with idiopathic basal arterial occlusive disease without moyamoya collaterals. Neurosurgery. 2010 Aug;67(2):278-85. doi: 10.1227/01.NEU.0000371977.55753.DE. — View Citation

Hallemeier CL, Rich KM, Grubb RL Jr, Chicoine MR, Moran CJ, Cross DT 3rd, Zipfel GJ, Dacey RG Jr, Derdeyn CP. Clinical features and outcome in North American adults with moyamoya phenomenon. Stroke. 2006 Jun;37(6):1490-6. Epub 2006 Apr 27. — View Citation

Jiang T, Perry A, Dacey RG Jr, Zipfel GJ, Derdeyn CP. Intracranial atherosclerotic disease associated with moyamoya collateral formation: histopathological findings. J Neurosurg. 2013 May;118(5):1030-4. doi: 10.3171/2013.1.JNS12565. Epub 2013 Feb 8. — View Citation

Zipfel GJ, Sagar J, Miller JP, Videen TO, Grubb RL Jr, Dacey RG Jr, Derdeyn CP. Cerebral hemodynamics as a predictor of stroke in adult patients with moyamoya disease: a prospective observational study. Neurosurg Focus. 2009 Apr;26(4):E6. doi: 10.3171/2009.01.FOCUS08305. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint: ipsilateral ischemic stroke.		6 month intervals for up to 5 years after enrollment
Secondary	Stroke specific quality of life (SSQOL), modified Rankin Scale, Barthel index		6 month intervals for up to 5 years after enrollment
Secondary	any stroke or death		6 month intervals for up to 5 years after enrollment