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NCT Number: NCT00495456

Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Box Hill Hospital, Box Hill, Victoria, Australia

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients above 18 years of age

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. To assess risk factors for cardiovascular disease.

    Time frame: Annually

Sponsors and collaborators

Lead sponsor

Monash University

Other

Registry information

Official study title

Cardiovascular Longitudinal Evaluation & Assessment of Risk Study

Acronym: CLEAR

Important dates

Study start
2007
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2007
Registry last updated
Apr 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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