NCT02388633

Acute Microvascular Changes With LDL Apheresis

Completed Results posted Last updated 1 April 2021

What this trial tests

trial testing Plasmapharesis in Hyperlipidemia in 8 participants. Completed in 1 July 2018.

Timeline

1 March 2015

Primary endpoint
1 July 2018

1 July 2018

Quick facts

Lead sponsor	Oregon Health and Science University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	8
Start date	1 March 2015
Primary completion	1 July 2018
Estimated completion	1 July 2018
Sites	1 location across United States

Drugs / interventions tested

• Plasmapharesis

Conditions studied

• Hyperlipidemia — all drugs for Hyperlipidemia →

Sponsor

Oregon Health and Science University

Who can join

19 and older, any sex, with Hyperlipidemia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Myocardial Perfusion at Rest Primary · 10 min

Acoustic intensity data were fit to the following function: y = A(1-e\^-beta\*t) where y is signal intensity at time t, A is the plateau intensity reflecting relative microvascular blood volume (MBV), and beta is the rate constant reflecting microvascular blood flux rate. Microvascular blood flow was quantified by the product of MBV and beta

Pre-apheresis

Group	Value	95% CI
Plasmapharesis	55	± 21

Post apheresis

Group	Value	95% CI
Plasmapharesis	135	± 65

Skeletal Muscle Perfusion at During Exercise Primary · 10 min

Contrast ultrasound assessment of microvascular perfusion of forearm skeletal muscle during contractile exercise.

Pre-apheresis

Group	Value	95% CI
Plasmapharesis	116	76 – 188

Post apheresis

Group	Value	95% CI
Plasmapharesis	118	52 – 249

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Lipoprotein Apheresis Acutely Reverses Coronary Microvascular Dysfunction in Patients With Severe Hypercholesterolemia.
   Wu MD, Moccetti F, Brown E, Davidson BP, et al · · 2019 · cited 26× · PMID 29909101 · DOI 10.1016/j.jcmg.2018.05.001