Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
András Komócsi, University of Pecs
ClinicalTrials.gov Identifier:
NCT00843102
First received: February 12, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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


Condition
Systemic Sclerosis

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by University of Pecs:

Primary Outcome Measures:
  • Occurrence of angiography proven coronary disease [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Occurence of pulmonary arterial hypertension [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum samples


Enrollment: 120
Study Start Date: December 2007
Study Completion Date: May 2012
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Systemic sclerosis

Criteria

Inclusion Criteria:

  • patients with rheumatologist established systemic sclerosis
  • informed consent

Exclusion Criteria:

  • left ventricular ejection fraction <30%
  • severly (<60% of predicted) deteriorated pulmonary function
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00843102

Locations
Hungary
University of Pécs, Hungary
Pécs, Hungary, H-7623
Sponsors and Collaborators
University of Pecs
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: András Komócsi, senior lecturer, University of Pecs
ClinicalTrials.gov Identifier: NCT00843102     History of Changes
Other Study ID Numbers: 330/PI/2007
Study First Received: February 12, 2009
Last Updated: June 12, 2012
Health Authority: Hungary:Health Scientific Council

Keywords provided by University of Pecs:
atherosclerosis
pulmonary hypertension

Additional relevant MeSH terms:
Scleroderma, Diffuse
Scleroderma, Systemic
Sclerosis
Connective Tissue Diseases
Pathologic Processes
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014