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Magnetic Resonance Imaging of Narrowed Arteries
This study has been completed.
Study NCT00029575   Information provided by National Institutes of Health Clinical Center (CC)
First Received: January 15, 2002   Last Updated: March 3, 2008   History of Changes

January 15, 2002
March 3, 2008
January 2002
 
 
 
Complete list of historical versions of study NCT00029575 on ClinicalTrials.gov Archive Site
 
 
 
Magnetic Resonance Imaging of Narrowed Arteries
Intravascular Narrow Field Magnetic Resonance Arterial Wall Imaging

This study will compare four methods of imaging arteries:

  • angiography (x-ray picture)
  • intravascular ultrasound (ultrasound from inside the artery)
  • magnetic resonance imaging (MRI) from outside the body
  • MRI using an antenna to take pictures inside the arteries of the pelvis

Standard angiography shows blockages inside the artery, but does not provide any information about the arterial wall itself. New ways of looking at the artery walls with MRI and ultrasound may provide insight into how arteries cause disease.

Patients 21 years of age and older who require catheterization and angiography of the heart, kidney, or leg arteries because of atherosclerosis (narrowing of the arteries), may be eligible for this study. Participants will undergo MRI and intravascular ultrasound of the arteries immediately after their catheterization and angiography. The additional imaging will add from 1 to 2 hours to the angiogram procedure.

  • Angiography: Using the sheaths already in place in the groin artery, catheters (flexible plastic tubes) are placed inside the arteries in order to inject a contrast dye to take x-ray pictures. (Patients who had an angiogram of the leg artery as part of their medical care will not repeat this test.)
  • Intravascular ultrasound: An anti-clotting drug called heparin is given through a vein to prevent clot formation. Blood samples are taken during the test to see if more heparin is needed. Special wires are used to guide the catheters to the proper location inside the arteries. A special ultrasound catheter is advanced over one of these wires to the large artery that supplies blood to the legs. X-rays are used to help the physician place the ultrasound in the correct location to take ultrasound pictures of the artery wall.
  • Magnetic resonance imaging: A special MRI catheter is advanced through the catheter in the groin. With the catheter in place, the patient is carried to a stretcher and moved into a long metal cylinder (the MRI scanner) for imaging. During the scanning, a contrast drug called gadolinium is injected into an arm vein to brighten the images. The patient is able to speak through a microphone at all times to the person taking the pictures.

Coronary artery disease remains the leading cause of death in the United States. Disruption of atherosclerotic plaque is associated with acute coronary syndromes including myocardial infarction, but culprit lesions are difficult to identify beforehand. Animal models of atherosclerosis have proven limited. In vivo plaque characterization might be useful both in plaque prognostication and in understanding human vascular biology. One imaging modality, high-resolution magnetic resonance imaging (MRI), has been shown feasible for plaque visualization and characterization, but still has important limitations. In this pilot study we hope to apply a new MRI modality using coils (antennae) that are inside the artery being studied, to achieve superior imaging.

This pilot study will examine whether intravascular arterial wall MRI can visualize the arterial wall with a higher spatial resolution than currently available techniques of intravascular ultrasound or conventional magnetic resonance imaging using surface receiver coils. In particular, we hope to image in high resolution, for the first time, the outer arterial wall (adventitia), which is not readily visualized. MRI using intravascular coils may also enable the study of blood flow and contrast accumulation within arterial walls, potentially key markers of plaque angiogenesis and vulnerability.

Phase I
Interventional
Treatment, Safety Study
Arteriosclerosis
Device: Surgi-Vision Guidewire Coil
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
25
December 2003
 

INCLUSION CRITERIA:

Adult patients undergoing a clinically driven transfemoral diagnostic or therapeutic cardiac or peripheral catheterization procedure

EXCLUSION CRITERIA - General:

Contraindication to Heparin

Patients less than 21 years old

Pregnant or lactating women

EXCLUSION CRITERIA - Contraindications to MRI:

Prior allergic reaction to Gadolinium contrast

Cardiac pacemaker or implantable defibrillator

Cerebral aneurysm clip

Neural stimulator (e.g. TENS-Unit)

Any type of ear implant

Metal in eye (e.g. from machining)

Any implanted device (e.g. insulin pump, drug infusion device)

EXCLUSION CRITERIA - Contraindications to Iodinated Contrast in a Research Study:

Serum creatinine greater than 2.0 mg/dl

Decompensated congestive heart failure

Both
 
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00029575
 
020071, 02-H-0071
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Institutes of Health Clinical Center (CC)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP