Multiple Burrhole Therapy With Erythropoietin for Unstable Moyamoya

NCT03162588 | Completed Phase 1

• 1 other identifier: AJIRB-MED-T12-11-065
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Attack; Ischemic Stroke; Moyamoya Disease; Burr Hole; Angiogenesis

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  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.

Study Arms (1)

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

Drug: erythropoietin

Interventions

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.

Also known as: multiple burrhole procedure

multiple burrhole therapy and erythropoietin

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ajou University School of Medicine: lead

Study Sites (1)

Ajou University Medical Center

Suwon, Gyunggido, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29626135 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Moyamoya Disease

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ji Man Hong

  assistant professor of neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Proffessor of Neurology

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: May 1, 2010
• Primary Completion: September 30, 2016
• Study Completion: September 30, 2016
• Last Updated: June 20, 2017

Record last verified: 2017-06

Locations

KR (1)