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Completed

NCT Number: NCT01419275

Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients

Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Xenon contrast agent

Drug

Other names: XeMED contrast agent

Magnetic Resonance Imaging

Device

Arterial spin label sequence for the purpose of measuring collateral flow

Primary outcomes

  1. Percentage of Regions With Collateral Versus Antegrade Blood Flow (Sensitivity) Correctly Identified Using MRI With Xenon Contrast Agent (Specificity)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Aug 18, 2011
Registry last updated
Aug 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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