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

NCT01419275 | Completed Results

• 1 other identifier: SU-06152011-7929
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cerebrovascular Accident; Moyamoya Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

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.

Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

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.

Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

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.

Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

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.

Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging

Interventions

Xenon contrast agent DRUG

Also known as: XeMED contrast agent

Acute stroke; Diagnosis unspecified; Healthy participants; Moyamoya

Magnetic Resonance Imaging DEVICE

Arterial spin label sequence for the purpose of measuring collateral flow

Acute stroke; Diagnosis unspecified; Healthy participants; Moyamoya

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients diagnosed with or suspected to have Moyamoya disease.
• 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.
• 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.
• Ability to comply with the MRI study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Stroke; Moyamoya Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; 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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Greg Zaharchuk
• Organization: Stanford University

susanmir@stanford.edu

650-736-6172

Study Officials

• Greg Zaharchuk

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 18, 2011
• Study Start: April 1, 2009
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: August 30, 2017
• Results First Posted: August 30, 2017

Record last verified: 2017-07

Locations

US (1)