Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2025-12-30 @ 6:14 PM
Study NCT ID:
NCT01210157
Status:
COMPLETED
Last Update Posted:
2010-09-28
First Post:
2010-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 373}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-27', 'studyFirstSubmitDate': '2010-08-11', 'studyFirstSubmitQcDate': '2010-09-27', 'lastUpdatePostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death from cardiac causes', 'timeFrame': 'up to five years'}], 'secondaryOutcomes': [{'measure': 'diagnosis of coronary artery disease (CAD)', 'timeFrame': 'up to five years'}, {'measure': 'diagnosis of cardiomypathy (CMP)', 'timeFrame': 'up to five years'}, {'measure': 'assessment of disease stage (CAD-1-3, NYHA I-IV)', 'timeFrame': 'up to five years'}, {'measure': 'non-fatal myocardial infarction or cerebrovascular accident', 'timeFrame': 'up to five years'}, {'measure': 'revascularization (percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG))', 'timeFrame': 'up to five years'}, {'measure': 'rehospitalization', 'timeFrame': 'up to five years'}, {'measure': 'implantation of ICD/biventricular pacemaker', 'timeFrame': 'up to five years'}, {'measure': 'heart transplantation', 'timeFrame': 'up to five years'}, {'measure': 'correlation with patient history', 'timeFrame': 'up to five years'}, {'measure': 'correlation with physical examination', 'timeFrame': 'up to five years'}, {'measure': 'correlation with routine lab values', 'timeFrame': 'up to five years'}, {'measure': 'correlation with ECG', 'timeFrame': 'up to five years'}, {'measure': 'correlation with echocardiography', 'timeFrame': 'up to five years'}, {'measure': 'correlation with cardiac MRI', 'timeFrame': 'up to five years'}, {'measure': 'correlation with cardiac CT', 'timeFrame': 'up to five years'}, {'measure': 'correlation with chest X-ray', 'timeFrame': 'up to five years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure', 'Cardiomyopathies', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether galectin-3 binding protein plasma levels can predict adverse cardiovascular events in patients with coronary artery disease and/or heart failure.', 'detailedDescription': 'Chronic heart failure represents an important cause of disease burden in Western countries. Heart failure can be either caused by vascular disease (i.e. cardiomypathy (CMP) due to coronary artery disease ("ischemic/ICMP")) or by myocardial conditions (i.e. dilated cardiomyopathies (DCMP) resulting from other causes like familial disposition, drug toxicity, etc.). Gold standard for the diagnosis of CMPs is the coronary angiography in conjunction with left ventricular angiography and myocardial biopsy, non-invasive markers include C-reactive protein (CRP) for ICMP and brain natriuretic protein (BNP) for DCMP. We have previously identified G3BP to be overexpressed in foam cells and plasma-derived microparticles, both potentially important in formation of atherosclerotic plaque. Galectin-3 binding protein (G3BP) is a secreted protein that is involved in cell adhesion and immune activation. The purpose of the current study is to test, whether G3BP plasma levels (a) are able to non-invasively differentiate causes of CMP and (b) are a suitable means for future risk assessment in CMP patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing coronary angiography.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* impaired ventricular function\n\nExclusion Criteria:\n\n* neoplastic disease\n* infections with hepatitis C or HIV'}, 'identificationModule': {'nctId': 'NCT01210157', 'acronym': 'GALACTIC', 'briefTitle': 'Galectin-3 Binding Protein in Cardiovascular Disease and Chronic Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'GALectin-3 Binding Protein for Risk Assessment in Coronary arTery dIsease and Chronic Heart Failure', 'orgStudyIdInfo': {'id': 'GL_LGALS3BP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'I Ischemic CMP', 'description': 'Patients with impaired ventricular function caused by coronary artery disease.'}, {'label': 'II CMP', 'description': 'Patients with impaired ventricular function which is not caused by coronary artery disease. Subgroups based on etiology (familial cardiomyopathy, toxic cardiomyopathy, etc.)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'University of Heidelberg, Dept. of Cardiology', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Christian A Gleissner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Christian A. Gleissner', 'oldOrganization': 'University of Heidelberg'}}}}