Endothelial Microparticles in Systemic Sclerosis Pulmonary Hypertension
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ClinicalTrials.gov Identifier: NCT02331225 |
Recruitment Status :
Completed
First Posted : January 6, 2015
Last Update Posted : December 16, 2016
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Condition or disease | Intervention/treatment |
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Systemic Sclerosis Pulmonary Hypertension Scleroderma | Other: No intervention given |
Study Type : | Observational |
Actual Enrollment : | 30 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Endothelial Mircroparticles as a Biomarker of Pulmonary Hypertension in Systemic Sclerosis |
Study Start Date : | December 2014 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | October 2016 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02331225
United States, Louisiana | |
LSU Health Sciences Center | |
New Orleans, Louisiana, United States, 70125 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Matthew Lammi, Assistant Professor of Medicine, Louisiana State University Health Sciences Center in New Orleans |
ClinicalTrials.gov Identifier: | NCT02331225 |
Other Study ID Numbers: |
8772 |
First Posted: | January 6, 2015 Key Record Dates |
Last Update Posted: | December 16, 2016 |
Last Verified: | December 2016 |
Hypertension, Pulmonary Hypertension Scleroderma, Systemic Scleroderma, Diffuse Sclerosis Vascular Diseases |
Cardiovascular Diseases Pathologic Processes Lung Diseases Respiratory Tract Diseases Connective Tissue Diseases Skin Diseases |