Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study
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Purpose
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.
| Condition |
|---|
|
Cardiovascular Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Cardiovascular Longitudinal Evaluation & Assessment of Risk Study |
| Estimated Enrollment: | 999999 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | December 2020 |
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Participants of current and future cardiovascular trials at the Centre of Clinical Research Excellence, Department of Epidemiology & Preventive Medicine, Monash University, Melbourne.
Inclusion Criteria:
- Patients above 18 years of age
Exclusion Criteria:
- Risk assessment would constitute harm to patient
- Informed consent not obtainable
Contacts and Locations| Contact: Chris Reid, BA DipEd MSc PhD | +61399030752 | Chris.Reid@med.monash.edu.au |
| Australia, Victoria | |
| Box Hill Hospital | Recruiting |
| Box Hill, Victoria, Australia | |
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |
| Caulfield General Medical Centre | Recruiting |
| Caulfield, Victoria, Australia | |
| Principal Investigator: Chris Reid, BA DipEd MSc PhD | |
| The Northern Hospital | Recruiting |
| Epping, Victoria, Australia | |
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |
| Alfred Hospital | Recruiting |
| Melbourne, Victoria, Australia, 3004 | |
| Principal Investigator: Dipak Kotecha, MBChB MRCP | |
| Principal Investigator: | Dipak Kotecha, MBChB MRCP | Monash University |
| Principal Investigator: | John Varigos, BSc | Monash University |
More Information
Additional Information:
No publications provided
| Responsible Party: | Prof Henry Krum, Monash University |
| ClinicalTrials.gov Identifier: | NCT00495456 History of Changes |
| Other Study ID Numbers: | CGMC 1-07 (CLEAR) |
| Study First Received: | July 2, 2007 |
| Last Updated: | March 8, 2012 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Monash University:
|
cardiovascular risk longitudinal prospective |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 16, 2013