Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-25 @ 4:58 PM
Study NCT ID:
NCT01781416
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2013-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 799}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-19', 'studyFirstSubmitDate': '2013-01-30', 'studyFirstSubmitQcDate': '2013-01-30', 'lastUpdatePostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-02-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)', 'timeFrame': 'Baseline'}, {'measure': 'Cardiovascular risk assessed by physicians', 'timeFrame': 'Baseline'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet', 'timeFrame': 'Baseline'}, {'measure': 'Actual cardiovascular risk calculated using SCORE', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR', 'timeFrame': 'Baseline'}, {'measure': 'Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR', 'timeFrame': 'Baseline'}, {'measure': 'Risk factors considered by patients in self-assessing their CVR', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular risk', 'SCORE', 'cardiovascular primary prevention', 'risk factors'], 'conditions': ['Cardiovascular Risk']}, 'descriptionModule': {'briefSummary': "This is a national, non interventional, prospective study performed in the general practice setting.\n\nThe study has been designed :\n\n* to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,\n* and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.", 'detailedDescription': 'LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adults aged 50 and over who :\n\n* are currently in primary prevention for a cardiovascular event,\n* are usually treated by the general practitioner,\n* and have a medical visit during the study period.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)\n* Usually treated by the GP\n* Having signed the information and consent form\n\nExclusion Criteria:\n\n* Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)\n* Patient unable to read and complete the study documentation'}, 'identificationModule': {'nctId': 'NCT01781416', 'acronym': 'PERCEPTION', 'briefTitle': 'Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk', 'orgStudyIdInfo': {'id': 'NIS-CFR-XXX-2012/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Research Site', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Atul PATHAK, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCE'}, {'name': 'Nicolas DANCHIN, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}