Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-03-02 @ 4:02 PM
Study NCT ID:
NCT00863967
Status:
UNKNOWN
Last Update Posted:
2009-03-18
First Post:
2009-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Arteriosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'C564658', 'term': 'Peripheral Arterial Occlusive Disease 1'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood / serum / white cells / plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 269}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-03-17', 'studyFirstSubmitDate': '2009-03-17', 'studyFirstSubmitQcDate': '2009-03-17', 'lastUpdatePostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular events', 'timeFrame': '10 years at least'}], 'secondaryOutcomes': [{'measure': 'Disease activity score', 'timeFrame': '2 / 5 / 10 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['physical examination', 'diagnostic techniques and procedures', 'diagnosis', 'immunologic tests', 'diagnostic tests', 'causality', 'genetic test', 'biomarker'], 'conditions': ['Arteriosclerosis', 'Atherosclerosis', 'Myocardial Infarction', 'Stroke', 'Diabetes Mellitus', 'Peripheral Arterial Occlusive Disease']}, 'referencesModule': {'references': [{'pmid': '12086762', 'type': 'BACKGROUND', 'citation': 'Biedermann BC, Sahner S, Gregor M, Tsakiris DA, Jeanneret C, Pober JS, Gratwohl A. Endothelial injury mediated by cytotoxic T lymphocytes and loss of microvessels in chronic graft versus host disease. Lancet. 2002 Jun 15;359(9323):2078-83. doi: 10.1016/S0140-6736(02)08907-9.'}, {'pmid': '12411948', 'type': 'BACKGROUND', 'citation': 'Binder CJ, Chang MK, Shaw PX, Miller YI, Hartvigsen K, Dewan A, Witztum JL. Innate and acquired immunity in atherogenesis. Nat Med. 2002 Nov;8(11):1218-26. doi: 10.1038/nm1102-1218. No abstract available.'}, {'pmid': '12124407', 'type': 'BACKGROUND', 'citation': 'Kiechl S, Lorenz E, Reindl M, Wiedermann CJ, Oberhollenzer F, Bonora E, Willeit J, Schwartz DA. Toll-like receptor 4 polymorphisms and atherogenesis. N Engl J Med. 2002 Jul 18;347(3):185-92. doi: 10.1056/NEJMoa012673.'}, {'pmid': '12840094', 'type': 'BACKGROUND', 'citation': 'Nabel EG. Cardiovascular disease. N Engl J Med. 2003 Jul 3;349(1):60-72. doi: 10.1056/NEJMra035098. No abstract available.'}, {'pmid': '11827921', 'type': 'BACKGROUND', 'citation': 'Nakajima T, Schulte S, Warrington KJ, Kopecky SL, Frye RL, Goronzy JJ, Weyand CM. T-cell-mediated lysis of endothelial cells in acute coronary syndromes. Circulation. 2002 Feb 5;105(5):570-5. doi: 10.1161/hc0502.103348.'}, {'pmid': '9887164', 'type': 'BACKGROUND', 'citation': 'Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.'}, {'pmid': '7732003', 'type': 'BACKGROUND', 'citation': 'Stemme S, Faber B, Holm J, Wiklund O, Witztum JL, Hansson GK. T lymphocytes from human atherosclerotic plaques recognize oxidized low density lipoprotein. Proc Natl Acad Sci U S A. 1995 Apr 25;92(9):3893-7. doi: 10.1073/pnas.92.9.3893.'}, {'pmid': '10052443', 'type': 'BACKGROUND', 'citation': 'Strong JP, Malcom GT, McMahan CA, Tracy RE, Newman WP 3rd, Herderick EE, Cornhill JF. Prevalence and extent of atherosclerosis in adolescents and young adults: implications for prevention from the Pathobiological Determinants of Atherosclerosis in Youth Study. JAMA. 1999 Feb 24;281(8):727-35. doi: 10.1001/jama.281.8.727.'}, {'pmid': '12477941', 'type': 'BACKGROUND', 'citation': 'Yamada Y, Izawa H, Ichihara S, Takatsu F, Ishihara H, Hirayama H, Sone T, Tanaka M, Yokota M. Prediction of the risk of myocardial infarction from polymorphisms in candidate genes. N Engl J Med. 2002 Dec 12;347(24):1916-23. doi: 10.1056/NEJMoa021445.'}]}, 'descriptionModule': {'briefSummary': 'Arteriosclerosis is a common chronic disease with well known risk factors like diabetes mellitus, hypertension, dyslipidemia, adipositas and smoking, leading to severe complications like myocardial infarction, stroke or peripheral arterial occlusive disease. In addition to life-style factors there is also a genetic predisposition to develop complicated atherosclerosis.\n\nObjective: Improve individual risk prediction by clinical phenotyping and genotyping.', 'detailedDescription': 'About 300 patients who are treated for various conditions at the department of general medicine at our hospital will be included prospectively in the study. This observational cohort will be followed for at least 10 years follow-up examinations.\n\nAt baseline and during follow up visits detailed clinical phenotyping is planned (medical and family history,standardized clinical and physical examinations, lab, RX, ECG, stress-test or echocardiogram). The genotyping is performed by DNA-isolation from leucocytes collected at baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'teaching hospital primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* informed consent\n\nExclusion Criteria:\n\n* life-threatening disease\n* life expectancy \\< 1 month\n* uncapable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT00863967', 'briefTitle': 'Early Detection of Arteriosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Baselland Bruderholz'}, 'officialTitle': 'Prospective Observational Cohort Study for Early Detection of Arteriosclerosis', 'orgStudyIdInfo': {'id': 'KSBH: 216/03'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'no cardiovascular events'}, {'label': '2', 'description': 'proven cardiovascular events'}, {'label': '3', 'description': 'possible cardiovascular events'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Barbara Biedermann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical Department Kantonsspital Bruderholz CH-4101 Bruderholz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Baselland Bruderholz', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Barbara Biedermann MD', 'oldOrganization': 'Department of medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz'}}}}