Portland, Oregon 97239


Purpose:

Severe hypercholesterolemia produced by conditions such as heterozygous familial hypercholesterolemia is associated with multiple complications including premature atherosclerotic disease. There is evidence that microvascular perfusion, particularly flow reserve, in critical organs is limited due to abnormalities in plasma viscosity, abnormal RBC deformability, and an imbalance between vasodilators and vasoconstrictors. There is little is currently known about acute changes in microvascular blood flow and microvascular rheology that occur in response to plasmapharesis which is used in some patients to lower critically elevated cholesterol levels. Our research group has pioneered CEU methods for assessing myocardial and skeletal muscle perfusion, and has previously demonstrated in pre-clinical models that acute hyperlipidemia produces a reduction in microvascular RBC transit rate. In this study, the investigators will assess acute changes in microvascular perfusion in patients undergoing clinically-indicated plasmapharesis.


Study summary:

Subjects who are scheduled to have planned apheresis treatment for severe hypercholesterolemia will be recruited into the study. They will undergo a screening evaluation, including a medical history, physical examination, ECG, and limited echocardiogram to evaluate for exclusion criteria. Before the apheresis procedure, blood samples will be obtained for plasma markers of inflammation, erythrocyte deformability, and plasma viscosity. Contrast enhanced ultrasound perfusion imaging will be performed to evaluate blood flow in the myocardium at rest, as well as in the forearm skeletal muscle before and after mild isometric exercise (50% maximal grip, 0.2 Hz). Flow mediated vasodilation will be performed. The subjects will then undergo their planned apheresis procedure. Within 2 hours of completion of apheresis, blood collection and CEU will be repeated. Plasma lipids will be available as part of the standard apharesis protocol.


Criteria:

Inclusion Criteria: - hypercholesterolemia (LDL >200 mg/dL) - clinically-indicated aphersis for hyperlipidemia - age >18 y.o. Exclusion Criteria: - pregnant or lactating females - hypersensitivity to ultrasound contrast agents - evidence for right to left or bidirectional shunt - on anticoagulants


NCT ID:

NCT02388633


Primary Contact:

Principal Investigator
Jonathan Lindner, MD
OSHU

Jonathan Lindner, MD
Phone: 503 494-8750
Email: lindnerj@ohsu.edu


Backup Contact:

N/A


Location Contact:

Portland, Oregon 97239
United States

Jonathan R Lindner, MD
Phone: 503-494-8750
Email: lindnerj@ohsu.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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