Biomarker-Led Optimization of Successful Surgical Outcomes in Moyamoya

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT06634004
Status
Enrolling By Invitation

Conditions

  • Moyamoya Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • BOLD MRI — OTHER
    The study will utilize the MRI diagnostic reactivity test to evaluate cerebrovascular reactivity in patients with moyamoya and healthy controls. All participants (patients and controls) receive the same diagnostic scan, and there is no cross-over, factorial, or sequential nature to the study.

Study Details

The goal of this work is to use advanced magnetic resonance imaging (MRI) methods to assess brain blood flow and vascular function in adults with moyamoya disease (MMD). MMD is a condition characterized by narrowing or obstruction of major arteries in the brain and people with MMD have a high risk of stroke. Study participants will be enrolled from Vanderbilt University Medical Center and Johns Hopkins Hospital and will undergo up to two MRI scans where measurements of cerebrovascular reserve are performed using inhaled room air mixed with 5% carbon dioxide. Scans will be performed before and after surgeries to treat MMD, all surgeries are clinically indicated and are not research procedures. To further understand how surgeries impact brain health, we will also perform neurological exams and cognitive testing at approximately the same time as the imaging scans. The overall goal is to incorporate advanced imaging and cognitive assessments to understand how surgeries improve brain health in these patients, and furthermore, to use this information to develop improved screening tools for stroke risk and decisions about surgery.

Key Dates

Start date
Sep 11, 2023
Status verified
Jan 2026
Primary completion
Sep 11, 2029
Completion
Sep 11, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Moyamoya
    Adults diagnosed with Moyamoya who are being considered for revascularization surgery.
  • Arm: Control
    Healthy adults who will under go a BOLD MRI for research purposes.

Primary Outcome Measure

Revascularization success [ Time Frame: 6 years ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21218-
Vanderbilt University Medical CenterNashvilleTennessee37212-

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Johns Hopkins University· Baltimore, MDVanderbilt University Medical Center· Nashville, TN

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