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Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moyamoya | Experimental | Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
|
| Acute stroke | Experimental | Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
|
| Healthy participants | Experimental | Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
|
| Diagnosis unspecified | Experimental | Approximately 60 participants with diagnosis unspecified will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon contrast agent | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | performed one time within 1 week prior to surgery |
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Inclusion Criteria:
Moyamoya Patient Inclusion Criteria:
Stroke Patient Inclusion Criteria:
Clinical Patient Acetazolamide MRI Inclusion Criteria:
Normal Subject Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Greg Zaharchuk | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moyamoya | Participants with Moyamoya disease received arterial spin label magnetic resonance imaging (MRI) with xenon contrast agent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moyamoya | Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | One participant did not undergo MRI and was not included in the analysis. | Posted | Number | 95% Confidence Interval | percentage of regions | performed one time within 1 week prior to surgery | Cerebral regions | Cerebral regions |
|
2 days
Observed subjects for allergic reactions or other adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moyamoya | Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Greg Zaharchuk | Stanford University | 650-736-6172 | susanmir@stanford.edu |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009072 | Moyamoya Disease |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Magnetic Resonance Imaging | Device | Arterial spin label sequence for the purpose of measuring collateral flow |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants with Moyamoya disease received arterial spin label MRI with xenon contrast agent. |
|
|
| 0 |
| 126 |
| 0 |
| 126 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002340 | Carotid Artery Diseases |
| D002539 | Cerebral Arterial Diseases |
| D020765 | Intracranial Arterial Diseases |
| D001157 | Arterial Occlusive Diseases |