Cerebrovascular Accident, Moyamoya Disease
Conditions
Brief summary
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
Detailed description
In the early hours following large vessel occlusion, the ultimate severity of the stroke is largely determined by the ability of collateral flow networks to supply blood to ischemic tissue via circuitous routes that bypass the proximal clot. Robust collateral flow can improve response to thrombolytic therapy and decrease the risk of intracranial hemorrhage. Despite their central importance, collaterals during acute stroke are poorly understood, largely because assessment has required an invasive imaging test, cerebral angiography. This proposal assesses whether a noncontrast MRI perfusion technique, called arterial spin labeling (ASL), can yield important information about collateral flow.
Interventions
DRUGXenon contrast agent
DEVICEMagnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Moyamoya Patient Inclusion Criteria: * Men and non-pregnant women, at least 21 years of age. * Outpatients seen at the Stanford Neurosurgery and Neurology Departments. * Ability to comply with all studies. * Inclusion of Moyamoya patients with Sulfa allergies. * Patients diagnosed with or suspected to have Moyamoya disease. Stroke Patient Inclusion Criteria: * Men and non-pregnant women, at least 21 years of age. * Patients admitted to the inpatient Stanford Stroke Service for stroke-like symptoms, less than 24 hours from last time seen normal. * Ability to comply with all studies. Clinical Patient Acetazolamide MRI Inclusion Criteria: * Men and non-pregnant women, at least 21 years of age. * Patients admitted to the inpatient Stanford Stroke Service or Neurosurgical -Service for symptoms compatible with cerebrovascular disease. * Ability to comply with all studies. Normal Subject Inclusion Criteria: * Ability to comply with the MRI study.
Exclusion criteria
* Level of consciousness score of 2 or greater as defined by the NIH stroke scale. * Symptoms likely related to psychoactive drugs or patients with symptoms related to an active inflammatory disease such as AIDS, meningitis, or cerebritis. * Psychiatric or substance abuse disorder or dementia that interferes with evaluation or interpretation of the neurologic and mental assessment of these patients. * Informed consent cannot be obtained either from the patient or legal representative. * Severe coexisting or terminal systemic disease that limits life expectancy or that may interfere with the conduct of the study. * Symptoms related to an alternative diagnosis such as seizures or migraine. * Patients receiving any thrombolytic agent or receiving acute stroke investigational drug therapies during the 30-day study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity) | performed one time within 1 week prior to surgery | Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such. |
Countries
United States
Participant flow
Recruitment details
Enrollment was closed prior to any enrollment in the acute stroke, healthy participant, and diagnosis unspecified groups, so results are presented for the Moyamoya group only.
Participants by arm
| Arm | Count |
|---|---|
| Moyamoya Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent. | 126 |
| Total | 126 |
Baseline characteristics
| Characteristic | Moyamoya |
|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 126 participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 126 |
| serious Total, serious adverse events | 0 / 126 |
Outcome results
Primary
Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)
Sensitivity and specificity for MRI-based ASL measure of presence of collaterals was measured using digital subtraction angiography as a gold standard. Measurements were for 20 regions per patient were scored as either positive or negative for collateral flow. A positive value (results) means the region is supplied by collateral flow. Negative means the region is supplied by antegrade (normal) flow. Sensitivity measures the proportion of positives that are correctly identified as such. Specificity measures the proportion of negatives that are correctly identified as such.
Time frame: performed one time within 1 week prior to surgery
Population: One participant did not undergo MRI and was not included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moyamoya | Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity) | Sensitivity | 81.7 percentage of regions |
| Moyamoya | Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity) | Specificity | 88.9 percentage of regions |