Viewing Study NCT00636766


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Study NCT ID: NCT00636766
Status: COMPLETED
Last Update Posted: 2012-11-02
First Post: 2008-03-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069059', 'term': 'Atorvastatin'}, {'id': 'D000077285', 'term': 'Rimonabant'}, {'id': 'D000077154', 'term': 'Rosiglitazone'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-01', 'studyFirstSubmitDate': '2008-03-11', 'studyFirstSubmitQcDate': '2008-03-11', 'lastUpdatePostDateStruct': {'date': '2012-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ultrasound and immunohistochemical parameters of plaque stability; novel cardiovascular risk factors', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Long-term cardiovascular outcomes', 'timeFrame': '3 years'}]}, 'conditionsModule': {'keywords': ['cardiovascular events'], 'conditions': ['Carotid Atherosclerosis', 'Stroke', 'Type 2 Diabetes', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '25453890', 'type': 'DERIVED', 'citation': 'Kadoglou NP, Moulakakis KG, Papadakis I, Ikonomidis I, Alepaki M, Spathis A, Karakitsos P, Lekakis J, Liapis CD. Differential effects of stent-graft fabrics on arterial stiffness in patients undergoing endovascular aneurysm repair. J Endovasc Ther. 2014 Dec;21(6):850-8. doi: 10.1583/14-4772MR.1.'}, {'pmid': '25264981', 'type': 'DERIVED', 'citation': 'Moustardas P, Kadoglou NP, Katsimpoulas M, Kapelouzou A, Kostomitsopoulos N, Karayannacos PE, Kostakis A, Liapis CD. The complementary effects of atorvastatin and exercise treatment on the composition and stability of the atherosclerotic plaques in ApoE knockout mice. PLoS One. 2014 Sep 29;9(9):e108240. doi: 10.1371/journal.pone.0108240. eCollection 2014.'}, {'pmid': '25142320', 'type': 'DERIVED', 'citation': 'Lambadiari V, Kadoglou NP, Stasinos V, Maratou E, Antoniadis A, Kolokathis F, Parissis J, Hatziagelaki E, Iliodromitis EK, Dimitriadis G. Serum levels of retinol-binding protein-4 are associated with the presence and severity of coronary artery disease. Cardiovasc Diabetol. 2014 Aug 21;13:121. doi: 10.1186/s12933-014-0121-z.'}, {'pmid': '25022935', 'type': 'DERIVED', 'citation': 'Kadoglou NP, Tahmatzidis DK, Giannakoulas C, Kapelouzou A, Gkontopoulos A, Parissis J, Lampropoulos S, Kottas G. Serum levels of novel adipokines, omentin-1 and chemerin, in patients with acute myocardial infarction: KOZANI STUDY. J Cardiovasc Med (Hagerstown). 2015 May;16(5):341-6. doi: 10.2459/JCM.0000000000000053.'}, {'pmid': '24956535', 'type': 'DERIVED', 'citation': 'Kadoglou NP, Lambadiari V, Gastounioti A, Gkekas C, Giannakopoulos TG, Koulia K, Maratou E, Alepaki M, Kakisis J, Karakitsos P, Nikita KS, Dimitriadis G, Liapis CD. The relationship of novel adipokines, RBP4 and omentin-1, with carotid atherosclerosis severity and vulnerability. Atherosclerosis. 2014 Aug;235(2):606-12. doi: 10.1016/j.atherosclerosis.2014.05.957. Epub 2014 Jun 8.'}, {'pmid': '24768795', 'type': 'DERIVED', 'citation': 'Kadoglou NP, Fotiadis G, Lambadiari V, Maratou E, Dimitriadis G, Liapis CD. Serum levels of novel adipokines in patients with acute ischemic stroke: potential contribution to diagnosis and prognosis. Peptides. 2014 Jul;57:12-6. doi: 10.1016/j.peptides.2014.04.008. Epub 2014 Apr 24.'}, {'pmid': '24464597', 'type': 'DERIVED', 'citation': 'Kadoglou NP, Sailer N, Fotiadis G, Kapelouzou A, Liapis CD. The impact of type 2 diabetes and atorvastatin treatment on serum levels of MMP-7 and MMP-8. Exp Clin Endocrinol Diabetes. 2014 Jan;122(1):44-9. doi: 10.1055/s-0033-1358762. Epub 2014 Jan 24.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to examine the atherosclerotic plaque stability using in vivo and in vitro techniques and to investigate the influence of exercise, anti-diabetic, lipid-lowering and cannabinoids receptor antagonists on atherosclerotic plaque texture in patients with cardiovascular risk and animals prone to atherosclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Carotid atherosclerosis\n* Femoral atherosclerosis\n* Cardiovascular risk\n\nExclusion Criteria:\n\n* Heart failure\n* Renal disease\n* Liver disease\n* Life-threatening diseases'}, 'identificationModule': {'nctId': 'NCT00636766', 'briefTitle': 'Diagnosis and Therapy of Vulnerable Atherosclerotic Plaque', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Atherosclerotic Plaque Texture-Experimental and Clinical Study on the Diagnostic and Therapeutic Strategies of Atherosclerotic Plaque Vulnerability', 'orgStudyIdInfo': {'id': '887/2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: atorvastatin', 'Drug: rimonabant', 'Drug: rosiglitazone', 'Drug: metformin']}], 'interventions': [{'name': 'atorvastatin', 'type': 'DRUG', 'description': 'A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)', 'armGroupLabels': ['1']}, {'name': 'rimonabant', 'type': 'DRUG', 'description': 'A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)', 'armGroupLabels': ['1']}, {'name': 'rosiglitazone', 'type': 'DRUG', 'description': 'A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)', 'armGroupLabels': ['1']}, {'name': 'metformin', 'type': 'DRUG', 'description': 'A:Experimental study of atherosclerosis B1:Effects of exercise on experimental atherosclerosis B2:Effects of exercise on high risk patients C1:Effects of statins on atherosclerotic plaque stability (experimental) C2:Effects of statins on atherosclerotic plaque stability (clinical) D:Effects of rosiglitazone and metformin on cardiovascular risk factors E:Effects of rimonabant on atherosclerotic plaque stability (experimental)', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Thessaloniki', 'country': 'Greece', 'facility': 'General Hospital of Thessaloniki "Hippokratio"', 'geoPoint': {'lat': 40.64072, 'lon': 22.93493}}], 'overallOfficials': [{'name': 'Christos Liapis, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Athens'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Nikolaos Kadoglou', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}