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In this study, the investigators aim to evaluate the indirect revascularization outcomes of a new combination therapy of multiple burrhole procedure with promotion of arteriogenesis by intravenous (IV) erythropoietin (EPO) pretreatment on Moyamoya patients with acute neurological presentation, and outline the clinical and vascular factors associated with revascularization through the burrholes.
This is a investigator led, single-center, single arm, interventional trial in prospective Moyamoya disease (MMD) and Moyamoya syndrome (MMS) registry. MMD or MMS patients with acute neurological presentation such as ischemic stroke or transient ischemic attack are eligible.
After inclusion, initial evaluation including transfemoral angiography is performed. A 3 day pre-procedure IV erythropoietin (120000 international units[IU] #3) is given for promotion of arteriogenesis, than multiple burrhole procedure is performed. Arteriogenesis is evaluated by 6 month transfemoral angiography.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| multiple burrhole therapy and erythropoietin | Experimental | pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| erythropoietin | Drug | Epokine®, CJ healthcare, South Korea is used preprocedurally to promote revascularization. Total 120,000 units of EPO is injected for three consecutive days, 40,000 units mixed in IV saline 100 ml over 1 hour. The multiple burrhole procedure is performed in area of hemodynamic insufficiency by D-SPECT. It is performed under local anesthesia. |
| Measure | Description | Time Frame |
|---|---|---|
| Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale. | The functional status of participants will be assessed based on modified Rankin Scale for evaluation of feasibility of procedure. | 6 month post-procedure |
| transdural arteriogenesis | the extent of collateral flow that has developed from external carotid artery to internal carotid artery through the burrholes | 6 month post-procedural cerebral angiography |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | periprocedural and post-procedural complications | Any complications occuring within <14 days of burrhole procedure + erythropoietin is classified as periprocedural complications. Any complications occuring or detected after 14 days of procedure up to 6 months will be classified as post-procedural. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ji Man Hong | assistant professor of neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Medical Center | Suwon | Gyunggido | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29626135 | Derived | Hong JM, Lee SJ, Lee JS, Choi MH, Lee SE, Choi JW, Lim YC. Feasibility of Multiple Burr Hole With Erythropoietin in Acute Moyamoya Patients. Stroke. 2018 May;49(5):1290-1295. doi: 10.1161/STROKEAHA.117.020566. Epub 2018 Apr 6. |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D009072 | Moyamoya Disease |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002340 | Carotid Artery Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |