N/A
Completed N=8
Acute Microvascular Changes With LDL Apheresis
Source: ClinicalTrials.gov NCT02388633 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcomePrimary: Myocardial Perfusion at Rest — 55; 135 IU/s
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Perfusion at Rest |
55; 135 | — |
| PRIMARY Skeletal Muscle Perfusion at During Exercise |
116; 118 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02388633). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.