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

July 29, 2017 updated by: Greg Zaharchuk, Stanford University
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Moyamoya
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
Other Names:
  • XeMED contrast agent
Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
EXPERIMENTAL: 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.
Drug: Xenon contrast agent
Other Names:
  • XeMED contrast agent
Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
EXPERIMENTAL: 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.
Drug: Xenon contrast agent
Other Names:
  • XeMED contrast agent
Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow
EXPERIMENTAL: 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.
Drug: Xenon contrast agent
Other Names:
  • XeMED contrast agent
Device: Magnetic Resonance Imaging
Arterial spin label sequence for the purpose of measuring collateral flow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
performed one time within 1 week prior to surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Greg Zaharchuk, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 17, 2011

First Posted (ESTIMATE)

August 18, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 30, 2017

Last Update Submitted That Met QC Criteria

July 29, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SU-06152011-7929

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Moyamoya Disease

Clinical Trials on Xenon contrast agent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe