Status:
COMPLETED
Effects of Low-density Lipoprotein (LDL) Apheresis on Inflammatory and Lipid Markers
Lead Sponsor:
Emory University
Collaborating Sponsors:
Kaneka Medical America LLC
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
3-70 years
Brief Summary
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-...
Detailed Description
Numerous epidemiological investigations have demonstrated the importance of cholesterol - specifically low density lipoprotein (LDL) - in the development and progression of atherosclerosis. A continui...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01138371
Start Date
March 1 2011
End Date
March 1 2012
Last Update
December 17 2013
Active Locations (1)
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1
Emory University Hospital
Atlanta, Georgia, United States, 30322