Study:
Clinical Implications of Peripheral Plaque Morphology
Rationale:
n/a
Purpose:
Peripheral Artery Disease involves a buildup of fatty deposits (plaque) within blood vessels
that can restrict blood flow. Patients who have PAD and claudication (pain in legs during
exercise due to poor blood circulation) may be eligible for this clinical trial. Three
primary hypotheses will be tested in this study: (1) IVUS (Intravascular Ultrasound)combined
with advanced digital image and signal processing provides a sensitive method to determine
plaque geometry and composition in the human peripheral artery wall; (2) IVUS can discern
specific arterial wall morphology, providing data that can be used to identify plaques that
predispose the patient to late complications; and (3) IVUS-derived plaque structure can be
used to predict responders and non-responders to pharmacologic therapy and percutaneous
endovascular interventions. These hypotheses will be tested as follows: (1) custom
engineered IVUS analysis software will be used to describe the geometry, composition, and
spatial component relationships of the vessel, (2) the morphology of lower extremity
arterial plaque, as determined by IVUS, will be correlated with baseline clinical
characteristics of subjects, and (3) the effects on plaque morphology after long term
treatment with antihyperlipidemics will be determined.
Study Status: Active, not recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Peripheral Artery Disease |
Other: Ivus (Intravascular Ultrasound) of Amputation Specimens
Procedure: IVUS (Intravascular Ultrasound)
Drug: Atorvastatin |
Phase 4 |
Verified by
The Cleveland Clinic
May, 2013
Sponsored by: The Cleveland Clinic
Information provided by: The Cleveland Clinic
ClinicalTrials.gov identifier: NCT00578422
Study Type: Interventional
Study Design: Observational Model: Case Control, Time Perspective: Prospective
Cleveland Clinic
Cleveland, Ohio 44067
United States
Daniel Clair, MD., Principal Investigator