The Role of Cerebral Hemodynamics in Moyamoya Disease

NCT ID: NCT00629915

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-10-31

Study Completion Date

2015-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Moyamoya Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Colin Derdeyn, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School Of Medicine, 510 South Kingshighway Blvd

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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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. doi: 10.1161/01.STR.0000221787.70503.ca. Epub 2006 Apr 27.

Reference Type BACKGROUND
PMID: 16645133 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19335132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20562658 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24402480 (View on PubMed)

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.

Reference Type RESULT
PMID: 19021845 (View on PubMed)

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.

Reference Type RESULT
PMID: 23394336 (View on PubMed)

Lee JJ, Shimony JS, Jafri H, Zazulia AR, Dacey RG Jr, Zipfel GR, Derdeyn CP. Hemodynamic Impairment Measured by Positron-Emission Tomography Is Regionally Associated with Decreased Cortical Thickness in Moyamoya Phenomenon. AJNR Am J Neuroradiol. 2018 Nov;39(11):2037-2044. doi: 10.3174/ajnr.A5812. Epub 2018 Oct 25.

Reference Type DERIVED
PMID: 30361434 (View on PubMed)

Derdeyn CP, Zipfel GJ, Zazulia AR, Davis PH, Prabhakaran S, Ivan CS, Aiyagari V, Sagar JR, Hantler N, Shinawi L, Lee JJ, Jafri H, Grubb RL Jr, Miller JP, Dacey RG Jr. Baseline Hemodynamic Impairment and Future Stroke Risk in Adult Idiopathic Moyamoya Phenomenon: Results of a Prospective Natural History Study. Stroke. 2017 Apr;48(4):894-899. doi: 10.1161/STROKEAHA.116.014538. Epub 2017 Mar 10.

Reference Type DERIVED
PMID: 28283605 (View on PubMed)

Other Identifiers

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R01NS051631

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201103026

Identifier Type: -

Identifier Source: org_study_id

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