Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-02 @ 10:05 PM
Study NCT ID:
NCT03111693
Status:
UNKNOWN
Last Update Posted:
2017-04-13
First Post:
2017-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CT Evaluation of Cardiovascular Risk Markers in Obese Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 123}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-07', 'studyFirstSubmitDate': '2017-03-30', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epicardial fat evaluation in obese population', 'timeFrame': 'at day 1'}], 'secondaryOutcomes': [{'measure': 'Calcium scoring evaluation', 'timeFrame': 'at day 1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epicardial fat', 'Obesity', 'Cardiovascular risks markers', 'Metabolic syndrome', 'Low dose computed tomography'], 'conditions': ['Epicardial Fat', 'Obesity', 'Cardiovascular Risks Markers', 'Metabolic Syndrome', 'Low Dose Computed Tomography']}, 'descriptionModule': {'briefSummary': 'Obesity is a chronic metabolic disorder : it leads to coronary heart disease and early atherosclerosis.\n\nCoronary artery calcium measured by CT is known as a robust predictor to predict risk for cardiac events in symptomatic and asymptomatic individuals. Furthermore, recent studies show that other CT risk factor exists, independent of calcium scoring, such as epicardial fat, intrathoracic fat and visceral fat.\n\nThe aim of this prospective study is to evaluate these new cardiovascular risk markers in obese patients, using standard dose CT and low dose CT with adaptative statistical iterative reconstruction.', 'detailedDescription': 'In this prospective single-center study, obese patients of our clinical nutrition service, hospitalized for nutritional assessement, are included.\n\nAll unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Healthcare), using prospective ECG-triggerring. The investigation protocol began with a standard-dose acquisition followed immediately by a low-dose acquisition, recorded over strictly identical segments (identical first and last sections).\n\nAfter these two examinations, estimated dose values are less than the diagnostic scan reference level for a coroCT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'obese population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* obesity \\>30 indicated non enhanced coroCT for calcium scoring.\n\nExclusion Criteria:\n\n* \\<18 ans\n* low Framingham scoring\n* pregnancy\n* not providing informed consent\n* history of cardiovascular disease.'}, 'identificationModule': {'nctId': 'NCT03111693', 'acronym': 'RisqOScan', 'briefTitle': 'CT Evaluation of Cardiovascular Risk Markers in Obese Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'CT Evaluation of Cardiovascular Risk Markers in Obese Patients', 'orgStudyIdInfo': {'id': 'CHU-312'}, 'secondaryIdInfos': [{'id': '2014-A00975-42', 'type': 'OTHER', 'domain': '2014-A00975-42'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'obese patients', 'description': 'obese patients of our clinical nutrition service, hospitalized for nutrional assessement, are included.', 'interventionNames': ['Other: Unenhanced Coro-CT']}], 'interventions': [{'name': 'Unenhanced Coro-CT', 'type': 'OTHER', 'description': 'All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring.', 'armGroupLabels': ['obese patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}, {'name': 'Lucie CASSAGNES', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'centralContacts': [{'name': 'Patrick LACARIN', 'role': 'CONTACT', 'email': 'placarin@chu-clermontferrand.fr', 'phone': '04 73 75 11 95'}], 'overallOfficials': [{'name': 'Lucie CASSAGNES', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}