Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT01521351
Status:
UNKNOWN
Last Update Posted:
2019-09-06
First Post:
2012-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Natural History of Carotid Atherosclerosis
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': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D000787', 'term': 'Angina Pectoris'}], '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': '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': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect if carotid ultrasound and carotid microwave radiometry measurements can predict the incidence of cerebrovascular and cardiovascular events in patients with coronary artery disease', 'timeFrame': '3 years', 'description': 'Microwave radiometry is a non invasive and safe technique that measures temperature of the internal tissues by detecting the normal radiation of the tissues in microwave frequencies. The primary outcome of the study is to see if the temperatures measured in the carotid arteries of patients with coronary artery disease can predict their outcome regarding cerebrovascular and cardiovascular events'}], 'secondaryOutcomes': [{'measure': 'Relation of other demographic factors with carotid ultrasound and microwave radiometry measurements and outcome', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['microwave radiometry', 'cardiovascular events', 'carotid artery disease', 'stroke', 'myocardial infarction'], 'conditions': ['Carotid Artery Disease', 'Stroke', 'Myocardial Infarction', 'Angina Pectoris']}, 'referencesModule': {'references': [{'pmid': '21256490', 'type': 'BACKGROUND', 'citation': 'Toutouzas K, Grassos H, Synetos A, Drakopoulou M, Tsiamis E, Moldovan C, Agrogiannis G, Patsouris E, Siores E, Stefanadis C. A new non-invasive method for detection of local inflammation in atherosclerotic plaques: experimental application of microwave radiometry. Atherosclerosis. 2011 Mar;215(1):82-9. doi: 10.1016/j.atherosclerosis.2010.12.019. Epub 2010 Dec 23. No abstract available.'}, {'pmid': '25370590', 'type': 'BACKGROUND', 'citation': 'Toutouzas K, Benetos G, Drakopoulou M, Deligianni C, Spengos K, Stefanadis C, Siores E, Tousoulis D. Incremental predictive value of carotid inflammation in acute ischemic stroke. Stroke. 2015 Jan;46(1):272-4. doi: 10.1161/STROKEAHA.114.007526. Epub 2014 Nov 4.'}, {'pmid': '24981292', 'type': 'BACKGROUND', 'citation': 'Toutouzas K, Benetos G, Drakopoulou M, Bounas P, Tsekoura D, Stathogiannis K, Koutagiar I, Aggeli C, Karanasos A, Panagiotakos D, Siores E, Stefanadis C. Insights from a thermography-based method suggesting higher carotid inflammation in patients with diabetes mellitus and coronary artery disease. Diabetes Metab. 2014 Dec;40(6):431-8. doi: 10.1016/j.diabet.2014.05.005. Epub 2014 Jun 26.'}, {'pmid': '23887842', 'type': 'BACKGROUND', 'citation': 'Toutouzas K, Benetos G, Drakopoulou M, Michelongona A, Nikolaou C, Masoura C, Stathogiannis K, Aggeli C, Tsiamis E, Siores E, Stefanadis C. Morphological and functional assessment of carotid plaques have similar predictive accuracy for coronary artery disease. Stroke. 2013 Sep;44(9):2607-9. doi: 10.1161/STROKEAHA.113.002462. Epub 2013 Jul 25.'}, {'pmid': '30571323', 'type': 'DERIVED', 'citation': 'Toutouzas K, Benetos G, Oikonomou G, Barampoutis N, Koutagiar I, Galanakos S, Karmpalioti M, Drakopoulou M, Stathogiannis K, Bounas P, Gata V, Antoniadou F, Davlouros P, Alexopoulos D, Hahalis G, Siores E, Sfikakis PP, Tousoulis D. Increase in Carotid Temperature Heterogeneity Is Associated With Cardiovascular and Cerebrovascular Events. Circ Cardiovasc Imaging. 2018 Nov;11(11):e008292. doi: 10.1161/CIRCIMAGING.118.008292. No abstract available.'}], 'seeAlsoLinks': [{'url': 'https://scholar.google.gr/citations?user=jksqG1sAAAAJ&hl=el', 'label': 'related info'}, {'url': 'http://www.hippocratio.gr/', 'label': 'Ippocration Hospital'}, {'url': 'https://en.uoa.gr/studies/postgraduate_programs/school_of_health_sciences/', 'label': 'University of Athens Medical School'}]}, 'descriptionModule': {'briefSummary': 'A prospective study of 700 patients with coronary artery disease will undergo non invasive evaluation of their carotid arteries by ultrasound and microwave radiometry. The patients will be followed up for 3 years and their outcome regarding the cardiovascular events (death, cardiac events, cerebrovascular events) will be recorded', 'detailedDescription': 'Carotid artery Thermal heterogeneity recorded by MR will be corelated to cardiovascular events (death, cardiac events, cerebrovascular events) as well as to all demographic (age, sex, hypertension, dyslipidemia, smoking status, etc) factors'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with coronary artery disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with coronary artery disease admitted in our hospital\n\nExclusion Criteria:\n\n* Patients with history of previous cerebrovascular event,\n* History of vasculitis, intermittent inflammatory, infectious, or neoplastic conditions likely to be associated with an acute-phase response.'}, 'identificationModule': {'nctId': 'NCT01521351', 'briefTitle': 'Natural History of Carotid Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'A Prospective Natural History Study of Carotid Atherosclerosis', 'orgStudyIdInfo': {'id': 'MRcar'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'carotid thermal heterogeneity', 'description': 'Patients that have carotid thermal heterogeneity detected by MR'}, {'label': 'no carotid thermal heterogeneity', 'description': 'Patients that DONT have carotid thermal heterogeneity detected by MR'}, {'label': 'carotid artery disease', 'description': 'Patients with detected carotid artery disease by ultrasound'}, {'label': 'no carotid artery disease', 'description': 'Patients with no carotid artery disease detected by ultrasound'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11528', 'city': 'Athens', 'state': 'Attica', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Andreas Synetos, MD', 'role': 'CONTACT', 'email': 'synetos@yahoo.com', 'phone': '00306945417784'}, {'name': 'Andreas Synetos, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'First Department of Cardiology, University of Athens, Medical School. Hippocratio Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Konstantinos Toutouzas', 'role': 'CONTACT', 'email': 'ktoutouz@gmail.com'}, {'name': 'Andreas Synetos', 'role': 'CONTACT', 'email': 'synetos@yahoo.com'}], 'overallOfficials': [{'name': 'Konstantinos Toutouzas', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First department of Cardiology, University of Athens Greece'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Cardiology', 'investigatorFullName': 'Konstantinos Toutouzas', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}