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Sponsored by: |
Hospices Civils de Lyon |
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Information provided by: | Hospices Civils de Lyon |
ClinicalTrials.gov Identifier: | NCT00697736 |
Systemic sclerodermia is a connectivity characterized by multiple visceral impairments, in particular pulmonary, which can lead to the development of a Pulmonary Arterial Hypertension (PAHT). In one hand, this PAHT is an evolutionary turn in symptomatology and prognosis, and on the other hand, the tracking and the analysis of its effects on the right ventricular function are difficult with the conventional techniques.
So, the analysis of the right ventricular function appears capital, because:
The aim of this trial is to identify in a population of 150 patients presenting a systemic scleroderma without PAHT:
This trial should allowed to define the place of the new right ventricular function markers in the evaluation of the functional consequences, the forecast and perhaps the care of systemic sclerodermic patients.
Condition | Intervention |
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Systemic Scleroderma |
Procedure: Echocardiography with myocardial tissular Doppler mode |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Cardiac Repercussion of Systemic Sclerodermias : Detection of Infra-Clinical Abnormalities by Analysis of the Myocardic Regional Function Using Myocardial Tissular Doppler Mode. |
Estimated Enrollment: | 150 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | March 2015 |
Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Age between 18 years and 75 years
And :
Either carrying a systemic sclerodermia satisfying the criteria of American College of Rheumatology (the presence of a major criteria or two minor criterias is required for the systemic diagnosis of sclerodermia):
Or presenting CREST syndrome, with at least 4 of the 5 following criterias :
Exclusion Criteria:
Contact: Genevieve DERUMEAUX, Pr | 33-4-7211-9087 | genevieve.derumeaux@chu-lyon.fr |
France | |
Hôpital Louis Pradel | Recruiting |
BRON Cedex, France, 69 677 | |
Principal Investigator: Genevieve DERUMEAUX, Pr |
Responsible Party: | Hospices Civils de Lyon ( Pr. Genevieve DERUMEAUX ) |
Study ID Numbers: | 2005.392 |
Study First Received: | June 12, 2008 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00697736 History of Changes |
Health Authority: | France: Ministry of Health |
Systemic Scleroderma Echocardiography |
Skin Diseases Connective Tissue Diseases Scleroderma |
Scleroderma, Diffuse Scleroderma, Systemic Congenital Abnormalities |
Skin Diseases Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic |