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Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00843102
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : June 13, 2012
Information provided by (Responsible Party):
András Komócsi, University of Pecs

Brief Summary:
Aim: Determination of frequency and nature of coronary involvement (including epicardial and microvascular) among scleroderma patients referred for right heart catheterization.

Condition or disease
Systemic Sclerosis

Detailed Description:

Systemic sclerosis (SSc)is a multiorgan autoimmune disease characterized by fibrosis of the skin and internal organs. Cardio-pulmonary manifestation in systemic sclerosis (SSc) patients has significant impact on the prognosis. Several elements of the heart and lung involvement encountered frequently in combination. Clinically apparent SSc cardiac involvement is recognized as poor prognostic factor, and in our experience it is the most frequent cause of death among SSc patients. Moreover arrhythmias, diastolic and less frequently systolic dysfunction considerably interfere with the quality of life of these patients. Cardiac involvement includes primary cardiac disorders like fibrosis of the contractile elements, ischemia due to the involved microcirculation and/or to the epicardial coronaries and some secondary ones like consequences of systemic or pulmonary hypertension.

Autopsy identifies fibrosis of the myocardium in up to 80 percent of cases. Its distribution is unrelated to epicardial coronary stenosis, and inflammatory processes are thought to play substantial role in its evolution. Microvascular disease (MVD) that causes reduction of the vasodilatory capacity independently from epicardial coronary disease (CAD), is known for several decades. Short term benefits from vasodilatory treatment has been also reported in some latest studies.

Symptoms of the elements of cardio-pulmonary involvement overlap and coronary abnormalities alike MVD were also found in asymptomatic patients. Recently prevalence of CAD is reported to be similar to gender, age and symptom matched controls. Atypical clinical presentations were predominant and nevertheless these findings indicate that SSc patients are not free from CAD.

Clarification the causes of reduced exercise capacity, chest pain and faint in SSc is a challenging task and requires multidisciplinary approach. Driven by its high mortality and due to the recent emergence of effective therapy SSc patients are regularly screened for pulmonary hypertension (PAH). Clinical presentation of scleroderma related PAH is unspecific. Fatigue, chest pain and dyspnea may be related to other organs, such as the lung, musculoskeletal system or the esophagus. The definitive diagnosis of PAH still depends on the results of right heart catheterization (RHC). As the non-invasive diagnostics are influenced and to some extent restricted by multiple clinical manifestations, RHC is performed liberally in symptomatic patients. Still a considerable proportion of patients who underwent RHC have normal pulmonary pressure and the cause of symptoms may remain obscure as cardiac involvement may not be correctly diagnosed or entirely overlooked.

We intend to characterize coronary artery disease in symptomatic SSc patients by means of a prospective cross-sectional study consisting of organized screening of SSc patients and systematic left heart catheterization (coronary angiography, and coronary flow reserve estimation) in all patients referred to RHC. Prognostic impact of the different manifestations are determined during five-year follow-up of the study.

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Study Type : Observational
Actual Enrollment : 120 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis
Study Start Date : December 2007
Actual Primary Completion Date : December 2009
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scleroderma

Primary Outcome Measures :
  1. Occurrence of angiography proven coronary disease [ Time Frame: 1 year ]
  2. Occurence of pulmonary arterial hypertension [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Overall mortality [ Time Frame: 5 years ]

Biospecimen Retention:   Samples Without DNA
Serum samples

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Systemic sclerosis

Inclusion Criteria:

  • patients with rheumatologist established systemic sclerosis
  • informed consent

Exclusion Criteria:

  • left ventricular ejection fraction <30%
  • severly (<60% of predicted) deteriorated pulmonary function

Information from the National Library of Medicine

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 identifier (NCT number): NCT00843102

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University of Pécs, Hungary
Pécs, Hungary, H-7623
Sponsors and Collaborators
University of Pecs
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: András Komócsi, senior lecturer, University of Pecs Identifier: NCT00843102    
Other Study ID Numbers: 330/PI/2007
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Keywords provided by András Komócsi, University of Pecs:
pulmonary hypertension
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases