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Endothelial Microparticles in Systemic Sclerosis Pulmonary Hypertension

NCT ID: NCT02331225

Last Updated: 2016-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Systemic Sclerosis Pulmonary Hypertension Scleroderma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Systemic sclerosis, no pulmonary hypertension

This group will be systemic sclerosis patients without pulmonary hypertension

No intervention given

Intervention Type OTHER

There is no intervention for this study

Systemic sclerosis/pulmonary hypertension

This group will be systemic sclerosis patients with pulmonary hypertension

No intervention given

Intervention Type OTHER

There is no intervention for this study

Healthy controls

These will be healthy age- and sex-matched controls

No intervention given

Intervention Type OTHER

There is no intervention for this study

Interventions

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No intervention given

There is no intervention for this study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


* Age\>18 years
* Age- and sex-matched to SSc patients

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:


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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of South Alabama

OTHER

Sponsor Role collaborator

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Matthew Lammi

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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LSU Health Sciences Center

New Orleans, Louisiana, United States

Site Status

Countries

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United States

References

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Tual-Chalot S, Guibert C, Muller B, Savineau JP, Andriantsitohaina R, Martinez MC. Circulating microparticles from pulmonary hypertensive rats induce endothelial dysfunction. Am J Respir Crit Care Med. 2010 Jul 15;182(2):261-8. doi: 10.1164/rccm.200909-1347OC. Epub 2010 Mar 25.

Reference Type BACKGROUND
PMID: 20339146 (View on PubMed)

Guiducci S, Distler JH, Jungel A, Huscher D, Huber LC, Michel BA, Gay RE, Pisetsky DS, Gay S, Matucci-Cerinic M, Distler O. The relationship between plasma microparticles and disease manifestations in patients with systemic sclerosis. Arthritis Rheum. 2008 Sep;58(9):2845-53. doi: 10.1002/art.23735.

Reference Type BACKGROUND
PMID: 18759303 (View on PubMed)

Iversen LV, Ostergaard O, Ullman S, Nielsen CT, Halberg P, Karlsmark T, Heegaard NH, Jacobsen S. Circulating microparticles and plasma levels of soluble E- and P-selectins in patients with systemic sclerosis. Scand J Rheumatol. 2013;42(6):473-82. doi: 10.3109/03009742.2013.796403. Epub 2013 Sep 9.

Reference Type BACKGROUND
PMID: 24016306 (View on PubMed)

Amabile N, Heiss C, Real WM, Minasi P, McGlothlin D, Rame EJ, Grossman W, De Marco T, Yeghiazarians Y. Circulating endothelial microparticle levels predict hemodynamic severity of pulmonary hypertension. Am J Respir Crit Care Med. 2008 Jun 1;177(11):1268-75. doi: 10.1164/rccm.200710-1458OC. Epub 2008 Feb 28.

Reference Type BACKGROUND
PMID: 18310479 (View on PubMed)

Amabile N, Heiss C, Chang V, Angeli FS, Damon L, Rame EJ, McGlothlin D, Grossman W, De Marco T, Yeghiazarians Y. Increased CD62e(+) endothelial microparticle levels predict poor outcome in pulmonary hypertension patients. J Heart Lung Transplant. 2009 Oct;28(10):1081-6. doi: 10.1016/j.healun.2009.06.005.

Reference Type BACKGROUND
PMID: 19782291 (View on PubMed)

Lammi MR, Saketkoo LA, Okpechi SC, Ghonim MA, Wyczechowska D, Bauer N, Pyakurel K, Saito S, deBoisblanc BP, Boulares AH. Microparticles in systemic sclerosis: Potential pro-inflammatory mediators and pulmonary hypertension biomarkers. Respirology. 2019 Jul;24(7):675-683. doi: 10.1111/resp.13500. Epub 2019 Feb 12.

Reference Type DERIVED
PMID: 30747487 (View on PubMed)

Other Identifiers

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8772

Identifier Type: -

Identifier Source: org_study_id