Peripheral Arterial Disease Clinical Trial
Official title:
Effect of Lipid Modification on Peripheral Arterial Disease After Endovascular Intervention ("The ELIMIT Trial")
Verified date | January 2020 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Peripheral arterial disease (PAD) occurs when arteries become narrowed or hardened because of a build-up of plaque or fat deposits. PAD develops most often in arteries in the legs, which can result in reduced blood flow to the legs and feet, occasionally causing leg pain and fatigue. Early identification of PAD and treatment with lifestyle changes or medications can help to keep legs healthy and lower risk for heart attack and stroke, but endovascular or surgical procedures may be necessary for people with severe PAD. Even after endovascular intervention, PAD symptoms must be continually monitored to prevent the development and progression of blockages in the arteries. The best approach for monitoring symptoms is still undetermined. This study will compare the effectiveness of an intensive combination of lipid modifying medications versus standard lipid modifying medications in treating people with significant PAD who have had an endovascular intervention.
Status | Completed |
Enrollment | 102 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Symptoms consistent with calf claudication and described as life style limiting - Objective evidence of peripheral artery disease (PAD): Ankle brachial index less than 0.9 OR other hemodynamic or imaging modalities confirming significant PAD - Baseline imaging reveals superficial femoral artery (SFA) disease starting at least 5 cm from the origin of the SFA - Agrees to be available for follow-up and is able to participate in all study testing procedures - Weight and/or body characteristics that will allow testing with MRI - No known contraindication to lipid lowering agents - Serum creatinine level less than 2.5 mg/dL - Scheduled to undergo or has already undergone an endovascular intervention of a de novo lesion in the SFA with an anticipated result that would satisfy hemodynamic stability OR is medically managed and does not require an intervention at this time - Compressible arteries (if not, has toe brachial index [TBI] less than 0.7) - Has/had an A, B, C lesion amendable to a catheter based therapy (prior bypass is acceptable) Exclusion Criteria: - Non-atherosclerotic disease that is responsible for claudication - Unstable cardiac disease (e.g., unstable angina, heart attack within the 30 days before study entry, uncontrolled coronary heart failure, poorly controlled hypertension [systolic blood pressure greater than 180 mmHg and/or diastolic blood pressure greater than 100 mmHg], ventricular arrhythmias) - Pancreatitis - Documented hypercoagulable state - Clinically severe diabetic neuropathy - Rest pain, gangrene, or tissue loss - Active peptic ulcer disease or a recent gastrointestinal bleed that would prohibit the use of an anti-platelet (aspirin/Plavix) - Untreated or unsuccessfully controlled psychiatric disease - Chronic hepatic disease determined by aspartate transaminase (AST) and/or alanine transaminase (ALT) more than 3 times upper limit of normal (ULN) and/or total bilirubin more than 2 times ULN - Creatine phosphokinase (CPK) more than 3 times ULN (may be repeated once before patient is excluded) - Active gout symptoms or a uric acid level greater than 1.3 times ULN - Untreated hypothyroidism - Allergy to Plavix, nickel, titanium, niacin, Ezetimibe, statins, or their derivatives - Participated in another interventional study within the 30 days before study entry - Scheduled to undergo planned synchronous bilateral percutaneous transluminal angioplasty (PTA) procedures - Requires an above the ankle amputation - Scheduled to undergo elective surgery within 30 days after the PTA procedure - Has an implanted pacemaker, defibrillator, neural stimulator, brain clip, insulin pump, cochlear implant, or any other predetermined radiographic finding that would exclude MRI testing - Has claustrophobia that would prevent MRI testing - Recent drug or alcohol abuse history (less than 6 months before study entry) or is currently using or abusing excessive alcohol or drugs (excessive alcohol will be defined as greater than 14 drinks per week) - Past recipient of a cardiac, kidney, liver, lung, or other organ transplant (skin grafts are acceptable) |
Country | Name | City | State |
---|---|---|---|
United States | Baylor College of Medicine | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Brunner G, Yang EY, Kumar A, Sun W, Virani SS, Negi SI, Murray T, Lin PH, Hoogeveen RC, Chen C, Dong JF, Kougias P, Taylor A, Lumsden AB, Nambi V, Ballantyne CM, Morrisett JD. The Effect of Lipid Modification on Peripheral Artery Disease after Endovascula — View Citation
Lumsden AB, Rice TW, Chen C, Zhou W, Lin PH, Bray P, Morrisett J, Nambi V, Ballantyne C. Peripheral arterial occlusive disease: magnetic resonance imaging and the role of aggressive medical management. World J Surg. 2007 Apr;31(4):695-704. Review. — View Citation
Saunders J, Nambi V, Kimball KT, Virani SS, Morrisett JD, Lumsden AB, Ballantyne CM, Dong JF; ELIMIT Investigators. Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients. J Vasc Surg. 2011 Mar;53(3):668-75 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Intensive Lipid Modification Medication Therapy on Progression of Atherosclerosis and Restenosis of Femoral Arteries Measured Using High Resolution Magnetic Resonance Imaging (MRI) to Examine the Femoral Artery for Progression of Atherosclerosis | The primary outcome variable was the change in superficial femoral artery (SFA) wall volume over 24-months, as determined by MRI. The 24-month changes in SFA lumen and SFA total vessel volumes were also analyzed. Analysis details: A total of 102 patients were randomized. 87 patients completed baseline MRI. Between randomization and the baseline visit, 1 patient withdrew from the study, 8 patients opted out from baseline imaging, and 6 additional patients declined blood collection at baseline. The multilevel models (primary endpoint) used all available imaging data (n=91), including patients who only completed baseline imaging (n=20) or completed at least 2 imaging visits other than baseline (n=4). |
Measured at baseline and 24 Months | |
Secondary | Change in Total Cholesterol (mg/dl) From Baseline to Month 12 | Lipids: Total cholesterol (mg/dl); Lipid Data at 12-Months (change from baseline) [mg/dl]. | Measured at baseline and 12 months |
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