Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty
|ClinicalTrials.gov Identifier: NCT00015717|
Recruitment Status : Completed
First Posted : May 3, 2001
Last Update Posted : March 4, 2008
|First Submitted Date||May 2, 2001|
|First Posted Date||May 3, 2001|
|Last Update Posted Date||March 4, 2008|
|Start Date||April 2001|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00015717 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty|
|Official Title||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.
|Detailed Description||Recently cervico-cranial angioplasty and stenting (CCAS) has been introduced as alternative treatment for occlusive disease of the extracranial and the intracranial vessels. Temporary or permanent clinically detectable neurological deficits occur in up to 13% of all patients undergoing CASS and are usually related to distal embolization or hemodynamic insufficiency. Silent cerebral micro-emboli are known to occur in patients undergoing carotid endarterectomy and angioplasty but are believed to be of little clinical significance. Distal embolization may be a technical concern when performing CCAS and could cause silent cerebral ischemia. High resolution diffusion-weighted MRI may detect silent hyperacute ischemic lesions in patients undergoing CCAS and examination by a stroke neurologist may detect clinical deficits otherwise unrecognized.|
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Estimated Completion Date||March 2004|
|Primary Completion Date||Not Provided|
Men and women age 18 years or older admitted for angioplasty with or without stenting of any intra or extra-cranial vessel.
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.
|Ages||Child, Adult, Senior|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||010146
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2004|