Clinical trial NCT00495456: Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study
Official title: Cardiovascular Longitudinal Evaluation & Assessment of Risk Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Disease
Keywords: cardiovascular
risk
longitudinal
prospective
Lead sponsor: Monash University
Sponsor class: OTHER
First posted: 2007-07-03
Enrollment: 665
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of current and future cardiovascular trials at the Centre of Clinical Research Excellence, Department of Epidemiology \& Preventive Medicine, Monash University, Melbourne.

Brief summary: 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.

Detailed description: 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 criteria: Inclusion Criteria:

* Patients above 18 years of age

Exclusion Criteria:

* Risk assessment would constitute harm to patient
* Informed consent not obtainable

Primary outcomes:
measure: To assess risk factors for cardiovascular disease.
timeFrame: Annually
Secondary outcomes:
Other outcomes:
Locations:
city: Box Hill
country: Australia
facility: Box Hill Hospital
state: Victoria
city: Caulfield
country: Australia
facility: Caulfield General Medical Centre
state: Victoria
city: Epping
country: Australia
facility: The Northern Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
Study officials:
affiliation: Monash University
name: Dipak Kotecha, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University
name: John Varigos, BSc
role: PRINCIPAL_INVESTIGATOR
References: