Trial Outcomes & Findings for Acute Microvascular Changes With LDL Apheresis (NCT NCT02388633)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

8 participants

Primary outcome timeframe

10 min

Results posted on

2021-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Plasmapharesis Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis. Plasmapharesis: Clinically-indicated LDL apheresis
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acute Microvascular Changes With LDL Apheresis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Plasmapharesis n=8 Participants Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis. Plasmapharesis: Clinically-indicated LDL apheresis
Age, Continuous	56 years STANDARD_DEVIATION 11 • n=99 Participants
Sex: Female, Male Female	2 Participants n=99 Participants
Sex: Female, Male Male	6 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	8 participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Plasmapharesis n=8 Participants Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis. Plasmapharesis: Clinically-indicated LDL apheresis
Myocardial Perfusion at Rest Pre-apheresis	55 IU/s Standard Deviation 21
Myocardial Perfusion at Rest Post apheresis	135 IU/s Standard Deviation 65

PRIMARY outcome

Timeframe: 10 min

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

Outcome measures

Outcome measures
Measure	Plasmapharesis n=8 Participants Patients undergoing apheresis for elevated LDL. Patients will undergo contrast ultrasound perfusion imaging at rest and during forearm exercise at before and immediately after apheresis. Plasmapharesis: Clinically-indicated LDL apheresis
Skeletal Muscle Perfusion at During Exercise Pre-apheresis	116 IU/s Interval 76.0 to 188.0
Skeletal Muscle Perfusion at During Exercise Post apheresis	118 IU/s Interval 52.0 to 249.0

Adverse Events

Plasmapharesis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jonathan Lindner, MD

OregonHSU

Phone: 5034949191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place