- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00495456
Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study (CLEAR)
Cardiovascular Longitudinal Evaluation & Assessment of Risk Study
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).
Assessing 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.
The 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.
Standard 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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Design: Longitudinal cohort study
Objectives:
- Establish a database of cardiovascular risk factors
- Correlate with long-term cardiovascular outcomes
- Assign suitable volunteers to appropriate clinical studies
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Victoria
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Box Hill, Victoria, Australien
- Box Hill Hospital
-
Caulfield, Victoria, Australien
- Caulfield General Medical Centre
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Epping, Victoria, Australien
- The Northern Hospital
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Melbourne, Victoria, Australien, 3004
- Alfred Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients above 18 years of age
Exclusion Criteria:
- Risk assessment would constitute harm to patient
- Informed consent not obtainable
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
To assess risk factors for cardiovascular disease.
Tidsram: Annually
|
Annually
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dipak Kotecha, MBChB MRCP, Monash University
- Huvudutredare: John Varigos, BSc, Monash University
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CGMC 1-07 (CLEAR)
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