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

Cerebrovascular Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419275
• Other study ID #: SU-06152011-7929
• Status: Completed
• Phase: N/A
• First received: August 16, 2011
• Last updated: April 12, 2016
• Start date: April 2009
• Est. completion date: November 2013

Study information

• Verified date: April 2016
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Cerebrovascular Disorders
• Moyamoya Disease
• Stroke

Intervention

Drug:
• Xenon as contrast agent

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial spin labeling in magnetic resonance imaging to assess collateral blood flow		performed one time prior to surgery	No