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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00029575 |
Purpose
This study will compare four methods of imaging arteries:
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arteriosclerosis |
Device: Surgi-Vision Guidewire Coil |
Phase I |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | Intravascular Narrow Field Magnetic Resonance Arterial Wall Imaging |
| Estimated Enrollment: | 25 |
| Study Start Date: | January 2002 |
| Estimated Study Completion Date: | December 2003 |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
| ClinicalTrials.gov Identifier: | NCT00029575 History of Changes |
| Other Study ID Numbers: | 020071, 02-H-0071 |
| Study First Received: | January 15, 2002 |
| Last Updated: | March 3, 2008 |
| Health Authority: | United States: Federal Government |
|
Atherosclerotic Plaque Resolution Adventitia |
Ultrasound Cardiac Catheterization Arteriosclerosis Coronary Artery Disease |
|
Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases |