Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT00495456
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2007-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 665}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2007-07-02', 'studyFirstSubmitQcDate': '2007-07-02', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess risk factors for cardiovascular disease.', 'timeFrame': 'Annually'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cardiovascular', 'risk', 'longitudinal', 'prospective'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.med.monash.edu.au/epidemiology/', 'label': 'Department of Epidemiology \\& Preventive Medicine, Monash University'}]}, 'descriptionModule': {'briefSummary': "The burden of cardiovascular disease (CVD) is considerable, despite many advances in diagnosis, clinical management and drug therapy. The World Health Organization estimates 30% of global deaths are attributable to CVD and whilst mortality rates in developed countries are falling, it remains the largest single cause of death (WHO, 2007). Nineteen out of every 100 deaths in Australia are attributed to CVD, with an annual cost of $1.47 billion (AIHW, 2006).\n\nAssessing the risk of future cardiovascular events is traditionally based on a number of 'risk-factors' determined by observational clinical studies such as the Framingham cohort. Recent evidence however invalidates their use in both the highest and lowest risk groups and raises questions about applying such methods in changing risk-behaviour. A considerable number of new risk markers have surfaced in recent years (including various biomarkers, pulse wave velocity and measures of arterial function). Unfortunately their long-term predictive capacity is largely unknown, particularly when compared with existing risk factors.\n\nThe aims of this study are to provide objective longitudinal data for a wide variety of risk markers both in current use and in development. Participants of current on-going clinical studies at will be approached to lengthen their observation period for the purposes of determining long-term clinical outcomes.\n\nStandard clinical observations and data obtained within the participant's enrolled studies will be collated into an electronic database. All existing and future studies must have individual approval from an appropriate ethics committee with signed consent. The baseline studies and follow-up assessments of this cohort will be correlated with cardiovascular events, hospitalizations and mortality. In addition, volunteers can be directed to appropriate clinical studies in CVD, thereby enhancing recruitment, encouraging good quality clinical studies and advancing knowledge of cardiovascular disease prevention.", 'detailedDescription': 'Design: Longitudinal cohort study\n\nObjectives:\n\n* Establish a database of cardiovascular risk factors\n* Correlate with long-term cardiovascular outcomes\n* Assign suitable volunteers to appropriate clinical studies'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of current and future cardiovascular trials at the Centre of Clinical Research Excellence, Department of Epidemiology \\& Preventive Medicine, Monash University, Melbourne.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients above 18 years of age\n\nExclusion Criteria:\n\n* Risk assessment would constitute harm to patient\n* Informed consent not obtainable'}, 'identificationModule': {'nctId': 'NCT00495456', 'acronym': 'CLEAR', 'briefTitle': 'Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study', 'organization': {'class': 'OTHER', 'fullName': 'Monash University'}, 'officialTitle': 'Cardiovascular Longitudinal Evaluation & Assessment of Risk Study', 'orgStudyIdInfo': {'id': 'CGMC 1-07 (CLEAR)'}}, 'contactsLocationsModule': {'locations': [{'city': 'Box Hill', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Box Hill Hospital', 'geoPoint': {'lat': -37.81887, 'lon': 145.12545}}, {'city': 'Caulfield', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Caulfield General Medical Centre', 'geoPoint': {'lat': -37.88251, 'lon': 145.02288}}, {'city': 'Epping', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The Northern Hospital', 'geoPoint': {'lat': -37.65, 'lon': 145.03333}}, {'zip': '3004', 'city': 'Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Alfred Hospital', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}], 'overallOfficials': [{'name': 'Dipak Kotecha, MBChB MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}, {'name': 'John Varigos, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Monash University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monash University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Lecturer', 'investigatorFullName': 'Ingrid Hopper', 'investigatorAffiliation': 'Monash University'}}}}