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N/A N=8

Acute Microvascular Changes With LDL Apheresis

Hyperlipidemia

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Myocardial Perfusion at Rest — 55; 135 IU/s

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Plasmapharesis (Procedure)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
Oregon Health and Science University
Primary completion
Jul 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Myocardial Perfusion at Rest
55; 135
PRIMARY
Skeletal Muscle Perfusion at During Exercise
116; 118

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.

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
View full record on ClinicalTrials.gov →

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.

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