Familial Hypercholesterolemia Clinical Trial
Official title:
Inflammatory and Lipid Markers Pre- and Post-LDL Apheresis: A Multicenter Experience
The primary objective of this study is to measure how LDL apheresis affects levels of inflammatory and cholesterol markers in human beings. The investigators will address this question by drawing pre- and post-LDL apheresis blood from patients who are undergoing this procedure. A secondary objective of this study is to learn how specific inflammatory markers behave in our blood in terms of time to rebound back to normal levels. The investigators will address this question by drawing post-LDL apheresis blood at predetermined time intervals.
Numerous epidemiological investigations have demonstrated the importance of cholesterol -
specifically low density lipoprotein (LDL) - in the development and progression of
atherosclerosis. A continuing relationship between cholesterol level and coronary morbidity
has been established. The initial approach for managing elevated cholesterol includes
lifestyle interventions, namely eating a low fat diet, weight loss in overweight patients,
and regular aerobic exercise. Once lifestyle interventions have been applied, pharmacologic
therapy becomes a mainstay of therapy, conventionally with a statin followed by adjunctive
medicines as indicated. Certain populations that are refractory to aggressive
pharmacotherapy, however - such as patients who have familial hypercholesterolemia (FH) -
necessitate alternative means of lipid management. Therapeutic considerations in these
patients include LDL apheresis and a number of rare procedures such as partial ileal bypass,
liver transplantation, portocaval shunting, and possibly gene therapy in the future.
The anti-inflammatory effects of LDL apheresis and its effects on endothelial function are
not well known. Considering several pathways of atherogenesis, and inflammation as a central
mechanism thereof, LDL apheresis may theoretically provide synergistic benefit of lipid
lowering as well as proinflammatory agent lowering that can lead to significantly decreased
atherogenesis. This study looks to address these questions by assessing the effects of LDL
apheresis on inflammatory and lipid markers.
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Observational Model: Case-Only, Time Perspective: Prospective
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