Magnetic Resonance Imaging to Investigate Silent Strokes During Neck and Skull Angioplasty

NCT00015717 | Completed

• 2 other identifiers: 01014601-N-0146
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Ischemia

Keywords

Imaging; Complications; Stenosis; Treatment; Strokes; Cerebral Ischemia; Cranial Cervical Angioplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 years or older admitted for angioplasty with or without stenting of any intra or extra-cranial vessel.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 8969792 BACKGROUND

• 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.

  PMID: 10657409 BACKGROUND

• 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.

  PMID: 10663492 BACKGROUND

MeSH Terms

Conditions

Brain Ischemia; Constriction, Pathologic; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 2, 2001
• First Posted: May 3, 2001
• Study Start: April 1, 2001
• Study Completion: March 1, 2004
• Last Updated: March 4, 2008

Record last verified: 2004-03

Locations

US (1)