Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
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Purpose
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
| Condition |
|---|
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Cerebrovascular Accident Moyamoya Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients |
- Arterial spin labeling in magnetic resonance imaging to assess collateral blood flow [ Time Frame: performed one time prior to surgery ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Moyamoya patients
60 MOyamoya patients will be enrolled.
|
|
Acute Stroke
60 acute stroke patients will be enrolled
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normal and diagnosis unspecified
A sub-group of 60 patient without specified diagnoses and 30 normals will be enrolled.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
A total of 120 patients will be recruited (60 Moyamoya and 60 acute stroke). All Moyamoya patients will receive XeCT and MRI scans with ASL sequencing in addition to their standard clinical procedures. Acute stroke patients will receive 2 MRI studies each (one <24 hours from symptom onset, the other in the 3-5 day period for determination of final infarct size) and an acute xeCT study (totaling 120 MRI and 60 xeCT studies).
A subarm of the study will include an additional 60 patients and 30 normal subjects who will not receive xeCT or conventional angiography, but who will undergo a single 60 min MRI study with images acquired before and after 1 g of intravenous acetazolamide for the purposes of determining the feasibility of replacing xeCT-based methods.
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.
Contacts and Locations| Contact: Sandra Dunn | (650) 724-8278 | sandradunn@stanford.edu |
| United States, California | |
| Stanford University School of Medicine | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Sandra Dunn 650-724-8278 sandradunn@stanford.edu | |
| Principal Investigator: Greg Zaharchuk | |
| Principal Investigator: | Greg Zaharchuk | Stanford University |
More Information
No publications provided
| Responsible Party: | Stanford University |
| ClinicalTrials.gov Identifier: | NCT01419275 History of Changes |
| Other Study ID Numbers: | SU-06152011-7929 |
| Study First Received: | August 16, 2011 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cerebrovascular Disorders Moyamoya Disease 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 Cerebral Infarction Stroke Brain Infarction Brain Ischemia |
ClinicalTrials.gov processed this record on June 18, 2013