Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-07 @ 4:05 AM
Study NCT ID:
NCT00843102
Status:
COMPLETED
Last Update Posted:
2012-06-13
First Post:
2009-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-12', 'studyFirstSubmitDate': '2009-02-12', 'studyFirstSubmitQcDate': '2009-02-12', 'lastUpdatePostDateStruct': {'date': '2012-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of angiography proven coronary disease', 'timeFrame': '1 year'}, {'measure': 'Occurence of pulmonary arterial hypertension', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Overall mortality', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atherosclerosis', 'pulmonary hypertension'], 'conditions': ['Systemic Sclerosis']}, 'referencesModule': {'references': [{'pmid': '19158116', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '23942767', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'Aim: Determination of frequency and nature of coronary involvement (including epicardial and microvascular) among scleroderma patients referred for right heart catheterization.', 'detailedDescription': '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.\n\nAutopsy 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.\n\nSymptoms 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.\n\nClarification 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.\n\nWe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Systemic sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with rheumatologist established systemic sclerosis\n* informed consent\n\nExclusion Criteria:\n\n* left ventricular ejection fraction \\<30%\n* severly (\\<60% of predicted) deteriorated pulmonary function'}, 'identificationModule': {'nctId': 'NCT00843102', 'briefTitle': 'Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Investigation of Coronary and Pulmonary Circulatory Parameters in Systemic Sclerosis', 'orgStudyIdInfo': {'id': '330/PI/2007'}}, 'contactsLocationsModule': {'locations': [{'zip': 'H-7623', 'city': 'Pécs', 'country': 'Hungary', 'facility': 'University of Pécs, Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'senior lecturer', 'investigatorFullName': 'András Komócsi', 'investigatorAffiliation': 'University of Pecs'}}}}