MoyamoyaNCT00629915
The Role of Cerebral Hemodynamics in Moyamoya Disease
An observational study of Moyamoya and Stroke, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School Of Medicine, 510 South Kingshighway Blvd
St Louis, Missouri, 63110
About this study
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.
Read the detailed 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.
- Keywords
- Moyamoya, stroke
- Medical subject headings
- Moyamoya Disease, Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint: ipsilateral ischemic stroke.
Measured: 6 month intervals for up to 5 years after enrollment
Secondary outcomes (2)
Stroke specific quality of life (SSQOL), modified Rankin Scale, Barthel index
Measured: 6 month intervals for up to 5 years after enrollment
any stroke or death
Measured: 6 month intervals for up to 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startOct 2006
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MoyamoyaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Colin Derdeyn, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629915
- Sponsor's protocol ID
- 201103026
- Other IDs
- R01NS051631
- Status last verified
- May 2018
- First submitted
- 4 Mar 2008
- Last updated
- 7 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16645133Zipfel 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.
PubMed 19335132Goyal 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.
PubMed 20562658Arias 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.
PubMed 24402480Ashley 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.
PubMed 19021845Jiang 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.
PubMed 23394336Lee 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.
PubMed 30361434Derdeyn 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.
PubMed 28283605
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cerebral Hemodynamics in Moyamoya Disease
- ClinicalTrials.gov ID
- NCT00629915
- Acronym / sponsor ID
- 201103026
- Keywords
- Moyamoya, stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2006
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint: ipsilateral ischemic stroke.
Time frame: 6 month intervals for up to 5 years after enrollment
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2018.
- Background: PubMed 16645133Hallemeier 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.
- Background: PubMed 19335132Zipfel 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.
- Background: PubMed 20562658Goyal 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.
- Background: PubMed 24402480Arias 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.
- Results publication: PubMed 19021845Ashley 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.
- Results publication: PubMed 23394336Jiang 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.
- Derived from this study: PubMed 30361434Lee 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.
- Derived from this study: PubMed 28283605Derdeyn 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Derdeyn, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Moyamoya and Stroke, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint: ipsilateral ischemic stroke. (time frame: 6 month intervals for up to 5 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00629915, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2018.