Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers (INFLAME)
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Inflammatory and Lipid Markers Pre- and Post-LDL Apheresis: A Multicenter Experience|
- Lipid Marker Change [ Time Frame: 1 month ] [ Designated as safety issue: No ]We will measure the level of cholesterol markers in your blood before and after the LDL apheresis procedure with a blood draw.
- Inflammatory Marker Change [ Time Frame: 1 month ] [ Designated as safety issue: No ]We will measure the level of inflammatory markers in your blood before and after the LDL apheresis procedure with blood draws (for 2 apheresis sessions)
- Inflammatory Marker Rebound [ Time Frame: 2 days ] [ Designated as safety issue: No ]We will measure the level of inflammatory markers in your blood after LDL apheresis procedure the following morning, 24 hours after procedure, and on the second morning.
Biospecimen Retention: Samples Without DNA
Blood samples only
|Study Start Date:||March 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Procedure: LDL Apheresis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138371
|United States, Georgia|
|Emory University Hospital|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Laurence Sperling, MD||Emory University|
|Study Director:||Vimal Ramjee, MD||Emory University|