Recruiting - Ongoing
Factors predicting outcomes in
cardiopulmonary complications of scleroderma - Australia
Study sponsor:
Australian Scleroderma Interest Group (ASIG), under the auspices of
the Australian Rheumatology Association with an unrestricted
educational grant from from Actelion Australia
Coordinating center:
Rheumatology Unit, St Vincent’s Hospital Melbourne, Victoria,
Australia. Prinicipal Investigator: Dr Susanna Proudman, Dept of
Rheumatology, Royal Adelaide Hospital. Email: sproudman@internode.on.net
Project Officer and Registry Co-ordinator: Jill Byron, Email:
jill.byron@svhm.org.au
Other centers involved:
Royal Adelaide Hospital (South Australia), Royal Prince Alfred (New
South Wales), Royal Adelaide Hospital (South Australia), Royal Perth
Hospital (Western Australia), Maroochydore Rheumatology Unit
(Queensland) and eventually other centres in Australia
Design:
National prospective and longitudinal electronic registry of
clinical, laboratory and investigational parameters related to
scleroderma, MCTD and cardiopulmonary complications
Inclusion criteria:
Scleroderma patients who attend a national screening centre set up
by ASIG are invited to participate. Patients eligible for and
participating in the screening program (aged greater than 18 years
with a clinical diagnosis of SSc or MCTD according to either the
American College of Rheumatology criteria or the LeRoy criteria for
limited or diffuse scleroderma) and who have signed the research
consent form.
Exclusion criteria:
Patients unable to be screened due to difficulty accessing a
screening centre because of geographic isolation or poor mobility;
factors likely to limit compliance with screening requirements;
factors likely to render screening investigations unsafe (modified
protocol may be permitted); patients who do not wish to participate
in research component.
Primary outcome measure:
Prevalence of PAH and ILD in scleroderma and MCTD in Australia
Secondary outcome measures:
Factors predicting development and severity of PAH and ILD in
scleroderma and MCTD in Australia
Recruitment period:
The project is funded for an initial period of three years but
further funding will be sought to maintain the project longer term,
so recruitment will be ongoing.
Completion:
Open ended longitudinal study
Date of expected analysis:
Ongoing from end 2008