Clinical Implications of Peripheral Plaque Morphology - Full Text View

Sponsors and Collaborators:	The Cleveland Clinic National Institutes of Health (NIH)
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00578422

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.

Condition	Intervention	Phase
Peripheral Artery Disease	Other: In Vitro IVUS Plaque Studies Procedure: IVUS, Angiography Drug: Randomization to Control or Test Group	Phase IV

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Official Title:	Clinical Implications of Peripheral Plaque Morphology

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

1. Develop automated algorithms to determine plaque geometry and composition from IVUS "backscattered" data [ Time Frame: Dec. 2008 ] [ Designated as safety issue: No ]
2. Identify associations between plaque morphology and clinical presentation. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
3. Correlate the outcome of interventions with arterial plaque morphology [ Time Frame: December 2008 ] [ Designated as safety issue: No ]
4. Determine the effects of lipid lowering and antiplatelet agents on the progression and regression of peripheral arterial plaque. [ Time Frame: December 2008 ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2003
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 In Vitro IVUS Plaque Studies	Other: In Vitro IVUS Plaque Studies Human lower extremity arterial segments will be obtained at autopsy and from amputation specimens. All imaging studies and vessel fixation will be undertaken immediately upon vessel procurement; in most cases this will occur within 2 hours of dissection and within 24 hours of death. The ex vivo portion of the study will make use of 150 excised vessels obtained over a 48-month period from randomly selected autopsy cases. From these vessels we expect to collect data from a minimum of 560 plaques
2 Observational Study - Clinical Correlate: Plaque Structure and Composition	Procedure: IVUS, Angiography Standard diagnostic arteriographic images will be obtained. Appropriate oblique views will be acquired at the common femoral bifurcation. Next, IVUS will be performed (, obtaining ultrasound data from a 10 cm lower extremity artery.
3: Active Comparator Randomized Clinical Trial - Morphologic Effects of Antihyperlipidemic Agents	Procedure: IVUS, Angiography Standard diagnostic arteriographic images will be obtained. Appropriate oblique views will be acquired at the common femoral bifurcation. Next, IVUS will be performed (, obtaining ultrasound data from a 10 cm lower extremity artery. Drug: Randomization to Control or Test Group Blindy randomized to Control Group-Low dose Atorvastatin (10 mg daily)or Treatment Group- Atorvastatin (80 mg daily)

Detailed Description:

Advances in the pathophysiology of Peripheral Arterial Disease (PAD) have been limited by the inaccessibility of the blood vessels to precise diagnostic interrogation. Traditional methods for studying disease in the peripheral arterial blood vessels have significant limitations. The development and refinement of IVUS (Intravscular Ultrasound) has provided a powerful in vivo method to assess plaque morphology. The potential of IVUS to quantify the structure and geometry of normal and atherosclerotic peripheral arteries will allow one to characterize specific lesions and to distinguish which plaques will or will not lead to complications.

Three primary hypotheses will be tested in this study: (1) IVUS 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥18 years.
Symptoms of intermittent claudication, rest pain, or minor tissue loss (Rutherford Category I - V).99
Non invasive laboratory evidence of peripheral vascular disease.
Angiographic demonstration of a 100 mm patent segment of a lower extremity artery containing at least one visually estimated stenosis of 20 - 80% diameter reduction.

Exclusion Criteria:

Acute limb ischemia, defined by a significant change in symptoms (one category on the Rutherford scale99 within the previous 14 days).
Concurrent oral anticoagulant therapy that cannot be safely withheld.
Extensive tissue loss and/or gangrene which would result in an above knee or below knee amputation(s).

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578422

Contacts

Contact: Karen Vukich, RN	216-445-6321	vukichk@ccf.org
Contact: Donna Lach, RN	216-444-5896	lachd@ccf.org

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44060
Contact: Karen Vukich, RN 216-445-6321 vukichk@ccf.org
Contact: Lach Donna, RN 216-444-5896 lachd@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Daniel Clair, MD

Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( Daniel Clair, MD )
Study ID Numbers:	HL-03-003, R01 HL072751
Study First Received:	December 19, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00578422
Health Authority:	United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:

PAD
Peripheral Artery Disease
IVUS
Plaque

Study placed in the following topic categories:

Atorvastatin

ClinicalTrials.gov processed this record on January 16, 2009