Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study

Sponsor

Monash University (Other)

Overall Status

Completed

CT.gov ID

NCT00495456

Collaborator

(none)

665

Enrollment

Locations

172

Duration (Months)

166.3

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease

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

Study Design

Study Type:

Observational

Actual Enrollment :

665 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Cardiovascular Longitudinal Evaluation & Assessment of Risk Study

Study Start Date :

Aug 1, 2007

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

To assess risk factors for cardiovascular disease. [Annually]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients above 18 years of age

Exclusion Criteria:

Risk assessment would constitute harm to patient
Informed consent not obtainable

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Box Hill Hospital	Box Hill	Victoria	Australia
2	Caulfield General Medical Centre	Caulfield	Victoria	Australia
3	The Northern Hospital	Epping	Victoria	Australia
4	Alfred Hospital	Melbourne	Victoria	Australia	3004