Status:
COMPLETED
Imaging of Totally Blocked Arteries
Lead Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Atherosclerosis
Peripheral Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study will test how well a new contrast agent (dye) used in magnetic resonance imaging (MRI) can help visualize totally blocked arteries that normally supply blood to the neck, arms or legs. Curr...
Detailed Description
Repairing totally occluded peripheral arteries remains challenging because they are not visualized using available imaging technologies. Contrast-enhanced magnetic resonance angiography (CE-MRA), X-ra...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects with known cardiovascular disease will be eligible for participation in this protocol. The subject is eligible under the following conditions:
- Subject's age is greater than 18 years of age.
- Known occlusion of iliac, femoral, or brachiocephalic arteries.
- EXCLUSION CRITERIA:
- Subjects with absolute contraindications to MRI scanning will be excluded. These contraindications include subjects with the following devices:
- Implanted cardiac pacemaker or defibrillator.
- Central nervous system aneurysm clips.
- Implanted neural stimulator.
- Cochlear implant.
- Ocular foreign body (e.g. metal shavings).
- Insulin pump.
- Metal shrapnel or bullet.
- When subjects can provide evidence that their implanted device is labeled compatible with MRI, exceptions to the above exclusions can be made and recorded in the note.
- Furthermore, certain subject groups will be excluded because of the administration of MRI contrast agents. The weight limit is related to availability of investigational contrast agents. Because of recent concerns about Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing Dermopathy after gadobenate exposure in patients with end-stage renal disease, renal excretory function will be determined and patients with severe renal excretory dysfunction are excluded from this research protocol.
- Pregnant women (subjects who are uncertain as to whether they are pregnant will be required to have a quantitative serum pregnancy test within 72 hours) or lactating women.
- Subjects who have experienced an allergic reaction to gadolinium-based contrast agents.
- Subjects with hemoglobinopathies.
- Weight greater than 120 kg.
- Subjects with renal disease (eGFR less than 30 ml/min/1.73m(2), or receiving renal replacement therapy).
- The creatinine clearance will be estimated in all subjects as an estimated glomerular filtration rate (eGFR) using the abbreviated MDRD Formula.
Exclusion
Key Trial Info
Start Date :
April 5 2007
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00459446
Start Date
April 5 2007
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892