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NCT02388633 · ClinicalTrials.gov registry record
Acute Microvascular Changes With LDL Apheresis
A clinical trial, sponsored by Oregon Health and Science University.
- Completed
- Registry status
- 8
- Enrollment target
NCT02388633: Completed study, sponsored by Oregon Health and Science University.
NCT02388633 is a clinical trial that has completed, run by Oregon Health and Science University. The registered enrollment target is 8 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388633 has completed, sponsored by Oregon Health and Science University.
- COMPLETED
- Registry status
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- PROCEDURE Plasmapharesis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2015-03-01 |
| Est. Completion | 2018-07-01 |
What the finished NCT02388633 record still lists
NCT02388633 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 8 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Plasmapharesis is the first listed.
NCT02388633 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02388633 about?
NCT02388633 is a clinical study titled "Acute Microvascular Changes With LDL Apheresis". 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...
What is the current status of trial NCT02388633?
This trial is currently completed. The enrollment target is 8 participants. The study started on 2015-03-01. Estimated completion is 2018-07-01.
What interventions are being tested in trial NCT02388633?
The interventions under investigation include: Plasmapharesis (PROCEDURE).
Who is sponsoring clinical trial NCT02388633?
This trial is sponsored by Oregon Health and Science University, which has 546 total clinical trials registered on ClinicalTrials.gov.
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