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Systemic SclerosisNCT00843102

Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis

An observational study of Systemic Sclerosis, run by University of Pecs at 1 site in Hungary.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Systemic Sclerosis
How many people
120 participants
Where
1 siteHungary
Study dates
Dec 2007to May 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Systemic sclerosis

Who may be able to join

  • patients with rheumatologist established systemic sclerosis
  • informed consent

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hungary1 site
  • University of Pécs, Hungary

    Pécs, H-7623

Other trials in Hungary

About this study

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

Read the 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.

Keywords
atherosclerosis, pulmonary hypertension
Medical subject headings
Scleroderma, Systemic, Atherosclerosis, Hypertension, Pulmonary

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of angiography proven coronary disease

    Measured: 1 year

  2. Occurence of pulmonary arterial hypertension

    Measured: 1 year

Secondary outcomes (1)
  1. Overall mortality

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2009 (estimated)
  2. Study startDec 2007
  3. Primary completionDec 2009
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00843102
Sponsor's protocol ID
330/PI/2007
Status last verified
Jun 2012
First submitted
12 Feb 2009
Last updated
13 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • Komocsi A, Pinter T, Faludi R, Magyari B, Bozo J, Kumanovics G, Minier T, Radics J, Czirjak L. Overlap of coronary disease and pulmonary arterial hypertension in systemic sclerosis. Ann Rheum Dis. 2010 Jan;69(1):202-5. doi: 10.1136/ard.2008.096255.

    PubMed 19158116
  • Kolto G, Faludi R, Aradi D, Bartos B, Kumanovics G, Minier T, Czirjak L, Komocsi A. Impact of cardiac involvement on the risk of mortality among patients with systemic sclerosis: a 5-year follow-up of a single-center cohort. Clin Rheumatol. 2014 Feb;33(2):197-205. doi: 10.1007/s10067-013-2358-4. Epub 2013 Aug 14.

    PubMed 23942767

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Sclerosis, run by University of Pecs at 1 site in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of angiography proven coronary disease (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00843102, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2012.

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