Endothelial Microparticles in Systemic Sclerosis Pulmonary Hypertension

December 15, 2016 updated by: Matthew Lammi, Louisiana State University Health Sciences Center in New Orleans

Endothelial Mircroparticles as a Biomarker of Pulmonary Hypertension in Systemic Sclerosis

Systemic sclerosis (SSc, also known as scleroderma) is a disease characterized by fibrosis of the skin and organs, inflammation, and an abnormal endothelial cell lining inside of vessels. A common and deadly complication of SSc is pulmonary hypertension (PH), which is an abnormal elevation in the blood pressure within the lung blood vessels. Early identification and treatment of PH is important in SSc, and no clinical factors can predict which patients will develop PH with acceptable accuracy. A potential marker of PH in SSc is the presence of increased amounts of endothelial microparticles (EMPs), which are substances circulating in the blood that were released from damaged vessel wall endothelial lining. A main goal of this study is to investigate if there is a difference in EMP levels between SSc patients with and without PH. The investigators will also use human endothelial cells in a lab environment to test whether these EMPs isolated from SSc patients are actually causing damage to the vessel lining. Lastly, the investigators will investigate the potential benefit of a medication used after transplant, mycophenolate mofetil (MMF). This will be done by causing damage to isolated human endothelial cells and treating them with MMF. The main goal of this portion of our study is to see if EMP levels are reduced when cells are treated with MMF. Overall, the investigators anticipate the following outcomes of this study: 1) use EMP levels to differentiation patients with SSc who have PH from those without PH, 2) use EMPs to understand how endothelial damage occurs in SSc, and 3) use EMPs to help us develop new treatments for patients with vascular diseases.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70125
        • LSU Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There will be 3 groups: systemic sclerosis subjects with pulmonary hypertension, systemic sclerosis subjects without pulmonary hypertension, and healthy age- and sex-matched controls.

Description

For systemic sclerosis subjects:

Inclusion Criteria:

  • Age >18 years
  • Meet American College of Rheumatology criteria for systemic sclerosis

Exclusion Criteria:

  • Chronic kidney disease (estimated creatinine clearance <50mL/min)
  • Uncontrolled hypertension (diastolic blood pressure>120mmHg)
  • Acute coronary syndrome within the past 6 months
  • Chronic obstructive pulmonary disease
  • Diabetes mellitus
  • Hemolytic anemia
  • Active tobacco abuse

For healthy control subjects:

Inclusion Criteria:

  • Age>18 years
  • Age- and sex-matched to SSc patients

Exclusion criteria:

  • Coronary artery disease
  • Uncontrolled hypertension (diastolic blood pressure>120mmHg)
  • Chronic obstructive pulmonary disease
  • Chronic kidney disease
  • Diabetes mellitus
  • Hemolytic anemia
  • Active tobacco abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Systemic sclerosis, no pulmonary hypertension
This group will be systemic sclerosis patients without pulmonary hypertension
Other: No intervention given
There is no intervention for this study
Systemic sclerosis/pulmonary hypertension
This group will be systemic sclerosis patients with pulmonary hypertension
Other: No intervention given
There is no intervention for this study
Healthy controls
These will be healthy age- and sex-matched controls
Other: No intervention given
There is no intervention for this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma VE-cadherin + endothelial microparticle levels
Time Frame: Baseline
endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma PECAM+ endothelial microparticles
Time Frame: Baseline
endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1
Baseline
Plasma E-selectin + endothelial microparticles
Time Frame: Baseline
endothelial microparticles are expressed as microparticles per microliter of plasma. This is a cross-sectional analysis, so the measurements will be performed once, on study visit 1
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

University of South Alabama

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

January 2, 2015

First Posted (Estimate)

January 6, 2015

Study Record Updates

Last Update Posted (Estimate)

December 16, 2016

Last Update Submitted That Met QC Criteria

December 15, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8772 (Other Identifier: FHCRC IRB Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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