Effect of Evolocumab on Coronary Endothelial Function

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT03500302
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evolocumab — DRUG
    Evolocumab sq once a month for a total of two doses

Study Details

The investigators propose a pilot study using (1) MRI to assess coronary artery endothelial function, (2) brachial ultrasound to assess systemic endothelial function, (3) serum markers of inflammation and of endothelial cell function and (4) echocardiographic measures of left ventricular diastolic and systolic properties, before and following initiation of PCSK9 antibody in HIV positive subjects.

Key Dates

Start date
May 4, 2018
Status verified
Jul 2020
Primary completion
Nov 30, 2019
Completion
Nov 30, 2019

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Evolocumab
    All enrolled patients will receive evolocumab sq once a month for a total of two doses

Primary Outcome Measure

Coronary Endothelial Function as Assessed by Percent Coronary Artery Area Change With Isometric Handgrip Exercise [ Time Frame: 1 week and 6 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins UniversityBaltimoreMaryland21205-

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