- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00015717
Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty
Silent Cerebral Ischemia After Cervico-Cranial Angioplasty Detected by Diffusion-Weighted MRI
This study will use magnetic resonance imaging (MRI) to determine if silent strokes occur during angioplasty of the blood vessels in the neck or skull. Neck and skull angioplasties are relatively new procedures whose possible complications are still under investigation.
Patients 18 years of age or older who are admitted to Suburban Hospital in Bethesda, Maryland, for angioplasty of one or more of the blood vessels in the neck or skull may participate in this study. Participants must be able to undergo a brain MRI. Within 24 hours before their angioplasty, patients will provide a medical history and have a physical examination and brain MRI. The physical examination and MRI will be repeated within 24 hours after the angioplasty.
MRI is a diagnostic test that uses a magnetic field and radio waves to show structural and chemical changes in tissues. This technique is more sensitive than X-rays in detecting some changes that occur in diseases of the brain. For the procedure, the patient lies on a table that slides into a metal cylinder (the scanner). The confined space may produce anxiety in some patients, and patients can talk to the technician at all times during the procedure. Earplugs are provided to muffle loud knocking and pulsing noises that occur while the scanner is taking pictures. During the study, the contrast material gadolinium may be injected into an arm vein. Gadolinium "brightens" the pictures, producing better images of brain blood flow.
Patients will be contacted by telephone 30 days after the procedure to follow how they are doing and learn whether any complications resulted from the angioplasty.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institute of Neurological Disorders and Stroke (NINDS)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
INCLUSION CRITERIA:
Men and women age 18 years or older admitted for angioplasty with or without stenting of any intra or extra-cranial vessel.
EXCLUSION CRITERIA:
Any MRI contraindication (insulin pump, aneurysm clips, implanted neural stimulator, cardiac pacemaker or defibrillator, cochlear implant, metal shrapnel or bullet)
Patients with hyperperfusion syndrome following the angioplasty.
Patients with cardiovascular or respiratory instability.
Patients with severe peri-procedural stroke at risk for herniation.
Confused or encephalopathic patients who are unable to cooperate.
Pregnant women.
Lactating women
Study Plan
How is the study designed?
Collaborators and Investigators
Publications and helpful links
General Publications
- Gil-Peralta A, Mayol A, Marcos JR, Gonzalez A, Ruano J, Boza F, Duran F. Percutaneous transluminal angioplasty of the symptomatic atherosclerotic carotid arteries. Results, complications, and follow-up. Stroke. 1996 Dec;27(12):2271-3. doi: 10.1161/01.str.27.12.2271.
- Qureshi AI, Luft AR, Janardhan V, Suri MF, Sharma M, Lanzino G, Wakhloo AK, Guterman LR, Hopkins LN. Identification of patients at risk for periprocedural neurological deficits associated with carotid angioplasty and stenting. Stroke. 2000 Feb;31(2):376-82. doi: 10.1161/01.str.31.2.376.
- Lovblad KO, Pluschke W, Remonda L, Gruber-Wiest D, Do DD, Barth A, Kniemeyer HW, Bassetti C, Mattle HP, Schroth G. Diffusion-weighted MRI for monitoring neurovascular interventions. Neuroradiology. 2000 Feb;42(2):134-8. doi: 10.1007/s002340050032.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 010146
- 01-N-0146
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.
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