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

NCT ID: NCT01419275

Last Updated: 2017-08-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2013-11-30

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.

Conditions

Cerebrovascular Accident; Moyamoya Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Moyamoya

Approximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Group Type: EXPERIMENTAL

Xenon contrast agent

Intervention Type: DRUG

Magnetic Resonance Imaging

Intervention Type: DEVICE

Arterial spin label sequence for the purpose of measuring collateral flow

Acute stroke

Approximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Group Type: EXPERIMENTAL

Xenon contrast agent

Intervention Type: DRUG

Magnetic Resonance Imaging

Intervention Type: DEVICE

Arterial spin label sequence for the purpose of measuring collateral flow

Healthy participants

Approximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow.

Group Type: EXPERIMENTAL

Xenon contrast agent

Intervention Type: DRUG

Magnetic Resonance Imaging

Intervention Type: DEVICE

Arterial spin label sequence for the purpose of measuring collateral flow

Diagnosis unspecified

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.

Group Type: EXPERIMENTAL

Xenon contrast agent

Intervention Type: DRUG

Magnetic Resonance Imaging

Intervention Type: DEVICE

Arterial spin label sequence for the purpose of measuring collateral flow

Interventions

Xenon contrast agent

Intervention Type: DRUG

Magnetic Resonance Imaging

Arterial spin label sequence for the purpose of measuring collateral flow

Intervention Type: DEVICE

Other Intervention Names

XeMED contrast agent

Eligibility Criteria

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.

• 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.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Greg Zaharchuk

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Greg Zaharchuk

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-06152011-7929

Identifier Type: -

Identifier Source: org_study_id