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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01419275
• Date of registration: 16/08/2011
• Prospective Registration: No
• Primary sponsor: Stanford University
• Public title: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
• Scientific title: Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
• Date of first enrolment: April 2009
• Target sample size: 126
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01419275
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Greg Zaharchuk
• Affiliation: Stanford University

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Moyamoya Disease

Cerebrovascular Accident

Intervention(s)

Device: Magnetic Resonance Imaging

Drug: Xenon contrast agent

Primary Outcome(s)

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]

Secondary ID(s)

SU-06152011-7929

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 30/08/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01419275