Cerebrovascular AccidentNCT01419275
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
A study testing Xenon contrast agent and Magnetic Resonance Imaging in people with Cerebrovascular Accident and Moyamoya Disease, run by Stanford University at 1 site in United States.
Trial summary
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident, Moyamoya Disease
- What is being tested?
- Xenon contrast agent and Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
- Patients diagnosed with or suspected to have Moyamoya disease.
- Stroke Patient Inclusion Criteria:
Show all 15Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients
Read the 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
- Being tested
- Xenon contrast agent, Magnetic Resonance Imaging
- Medical subject headings
- Stroke, Moyamoya Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xenon contrast agentDrug
Also called XeMED contrast agent
Magnetic Resonance ImagingDevice
Arterial spin label sequence for the purpose of measuring collateral flow
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Xenon contrast agent; Device: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: performed one time within 1 week prior to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study startApr 2009
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Zaharchuk, Stanford University
- Investigators
- Greg Zaharchuk, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419275
- Sponsor's protocol ID
- SU-06152011-7929
- Status last verified
- Jul 2017
- First submitted
- 16 Aug 2011
- Last updated
- 30 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
- ClinicalTrials.gov ID
- NCT01419275
- Acronym / sponsor ID
- SU-06152011-7929
- Conditions
- Cerebrovascular Accident, Moyamoya Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 30 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Moyamoya | Experimental | Drug: Xenon contrast agent, Device: Magnetic Resonance ImagingApproximately 60 Moyamoya patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
| Acute stroke | Experimental | Drug: Xenon contrast agent, Device: Magnetic Resonance ImagingApproximately 60 acute stroke patients will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
| Healthy participants | Experimental | Drug: Xenon contrast agent, Device: Magnetic Resonance ImagingApproximately 30 healthy participants will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
| Diagnosis unspecified | Experimental | Drug: Xenon contrast agent, Device: Magnetic Resonance ImagingApproximately 60 participants with diagnosis unspecified will be enrolled, and will receive arterial spin label MRI with Xenon contrast agent to assess collateral blood flow. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xenon contrast agentAlso: XeMED contrast agent | Drug | Acute stroke, Diagnosis unspecified, Healthy participants, Moyamoya |
| Magnetic Resonance ImagingArterial spin label sequence for the purpose of measuring collateral flow | Device | Acute stroke, Diagnosis unspecified, Healthy participants, Moyamoya |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg Zaharchuk principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xenon contrast agent and Magnetic Resonance Imaging in people with Cerebrovascular Accident and Moyamoya Disease, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.