Back to resultsMultiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya
Primary Purpose
Ischemic Attack, Ischemic Stroke, Moyamoya Disease
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Attack
Eligibility Criteria
Inclusion Criteria:
- Age ≥16 years
- Acute neurological presentation with recurrent transient ischemic attacks (TIA) or cerebral infarction within 30 days of symptom onset
- Angiographic findings compatible with the diagnostic criteria for MMD or MMS (unilateral findings, bilateral distal internal carotid artery involvement without Moyamoya vessels, or presence of other causative factors)
- Significant decrease in basal perfusion and reservoir capacity on brain perfusion CT or Brain single photon emission computed tomography with acetazolamide (Diamox®) challenge (D-SPECT)
Exclusion Criteria:
- Definite presence of transdural collateral flow on cerebral angiography.
- Sufficient perfusion status via Willisian, leptomeningeal, or other collateral systems, as evaluated by multimodal imaging methods.
- > 30 days after symptom onset
Sites / Locations
- Ajou University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
multiple burrhole therapy and erythropoietin
Arm Description
pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed
Outcomes
Primary Outcome Measures
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.
transdural arteriogenesis
the extent of collateral flow that has developed from external carotid artery to internal carotid artery through the burrholes
Secondary Outcome Measures
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
periprocedural and post-procedural complications
Full Information
NCT ID
NCT03162588
First Posted
May 18, 2017
Last Updated
June 19, 2017
Sponsor
Ajou University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03162588
Brief Title
Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya
Official Title
Feasibility Study of Multiple Burrhole Therapy Combined With Intravenous Erythropoietin Pretreatment for Unstable Moyamoya
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 1, 2010 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ajou University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Attack, Ischemic Stroke, Moyamoya Disease, Burr Hole, Angiogenesis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
multiple burrhole therapy and erythropoietin
Arm Type
Experimental
Arm Description
pretreatment with IV erythropoietin for 3 days, 120000IU#3 then multiple burrhole procedure on the hemisphere effected is performed
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Other Intervention Name(s)
multiple burrhole procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional status of the participants after 6 months of procedure assessed by modified Rankin Scale.
Description
The functional status of participants will be assessed based on modified Rankin Scale for evaluation of feasibility of procedure.
Time Frame
6 month post-procedure
Title
transdural arteriogenesis
Description
the extent of collateral flow that has developed from external carotid artery to internal carotid artery through the burrholes
Time Frame
6 month post-procedural cerebral angiography
Secondary Outcome Measure Information:
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Description
periprocedural and post-procedural complications
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥16 years
Acute neurological presentation with recurrent transient ischemic attacks (TIA) or cerebral infarction within 30 days of symptom onset
Angiographic findings compatible with the diagnostic criteria for MMD or MMS (unilateral findings, bilateral distal internal carotid artery involvement without Moyamoya vessels, or presence of other causative factors)
Significant decrease in basal perfusion and reservoir capacity on brain perfusion CT or Brain single photon emission computed tomography with acetazolamide (Diamox®) challenge (D-SPECT)
Exclusion Criteria:
Definite presence of transdural collateral flow on cerebral angiography.
Sufficient perfusion status via Willisian, leptomeningeal, or other collateral systems, as evaluated by multimodal imaging methods.
> 30 days after symptom onset
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Man Hong
Organizational Affiliation
assistant professor of neurology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ajou University Medical Center
City
Suwon
State/Province
Gyunggido
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
29626135
Citation
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.
Results Reference
derived
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Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya
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