Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers

Completed

Conditions studied: Familial Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT01138371

Run by

Emory University

People needed

8

Starts

2011-03-01

Expected to finish

2012-03-01

Last updated by the study team

2013-12-17

Who can join

Age: 3 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Heterozygous FH with documented CAD and LDL-C ≥ 200 mg/dL Documented CAD may be represented as: Lesion(s) on coronary angiography, history of myocardial infarction, CABG, PTCA, progressive angina demonstrated by stress testing, history of other revascularization procedure (e.g. atherectomy)
• Homozygous FH and LDL-C > 500 mg/dL
• Heterozygous FH and LDL-C ≥ 300 mg/dL
• On stable LDL apheresis therapy for at least 6 months.

You may not qualify if…

• Patient refusal to participate
• Inability to attend 2 consecutive LDL apheresis sessions for study duration
• Subject with advanced renal disease
• Subject with chronic progressive hepatic disease and demonstrated deficient synthetic function
• Subject with acute hepatic process
• Subject with current malignancy
• Subject with diagnosis of amyloidosis
• Subject with diagnosis of rheumatoid arthritis
• Any subject with acute flare of chronic disease
• Subject with recent ethanol ingestion
• Subject with significant bone disease

Where it is running

• Emory University Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.