The Role of Cerebral Hemodynamics in Moyamoya Disease

NCT00629915 | Completed

• 2 other identifiers: 201103026R01NS051631
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Moyamoya; Stroke

Keywords

Moyamoya; stroke

Outcome Measures

Primary Outcomes (1)

• Primary endpoint: ipsilateral ischemic stroke.

  6 month intervals for up to 5 years after enrollment

Secondary Outcomes (2)

• Stroke specific quality of life (SSQOL), modified Rankin Scale, Barthel index

  6 month intervals for up to 5 years after enrollment

• any stroke or death

  6 month intervals for up to 5 years after enrollment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Washington University School Of Medicine, 510 South Kingshighway Blvd

St Louis, Missouri, 63110, United States

Location

Related Publications (8)

• 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.

  PMID: 16645133 BACKGROUND

• 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.

  PMID: 19335132 BACKGROUND

• 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.

  PMID: 20562658 BACKGROUND

• 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.

  PMID: 24402480 BACKGROUND

• 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.

  PMID: 19021845 RESULT

• 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.

  PMID: 23394336 RESULT

• 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.

  PMID: 30361434 DERIVED

• 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.

  PMID: 28283605 DERIVED

MeSH Terms

Conditions

Moyamoya Disease; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Colin Derdeyn, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 6, 2008
• Study Start: October 1, 2006
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 7, 2018

Record last verified: 2018-05

Locations

US (1)