Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients
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| First Received Date ICMJE | August 16, 2011 | ||||
| Last Updated Date | December 13, 2012 | ||||
| Start Date ICMJE | April 2009 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Arterial spin labeling in magnetic resonance imaging to assess collateral blood flow [ Time Frame: performed one time prior to surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT01419275 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients | ||||
| Official Title ICMJE | Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya Disease and Stroke Patients | ||||
| Brief Summary | Quantifying Collateral Perfusion in Cerebrovascular Disease-Moyamoya disease and stroke patients |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | A total of 120 patients will be recruited (60 Moyamoya and 60 acute stroke). All Moyamoya patients will receive XeCT and MRI scans with ASL sequencing in addition to their standard clinical procedures. Acute stroke patients will receive 2 MRI studies each (one <24 hours from symptom onset, the other in the 3-5 day period for determination of final infarct size) and an acute xeCT study (totaling 120 MRI and 60 xeCT studies). A subarm of the study will include an additional 60 patients and 30 normal subjects who will not receive xeCT or conventional angiography, but who will undergo a single 60 min MRI study with images acquired before and after 1 g of intravenous acetazolamide for the purposes of determining the feasibility of replacing xeCT-based methods. |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | April 2014 | ||||
| Estimated Primary Completion Date | April 2014 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Moyamoya Patient Inclusion Criteria:
Stroke Patient Inclusion Criteria:
Clinical Patient Acetazolamide MRI Inclusion Criteria:
Normal Subject Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01419275 | ||||
| Other Study ID Numbers ICMJE | SU-06152011-7929 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Stanford University | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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