Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00015717
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-05-02
Brief Title:
Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Silent Cerebral Ischemia After Cervico-Cranial Angioplasty Detected by Diffusion-Weighted MRI
Status:
COMPLETED
Status Verified Date:
2004-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-N-0146 | None | None | None |