Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study

NCT00495456 | Completed DMC

• 1 other identifier: CGMC 1-07 (CLEAR)
• Study Type: observational
• Target: 665
• Locations: 1 country
• Sites: 4

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.

Conditions

Cardiovascular Disease

Keywords

cardiovascular; risk; longitudinal; prospective

Outcome Measures

Primary Outcomes (1)

• To assess risk factors for cardiovascular disease.

  Annually

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients above 18 years of age

You may not qualify if:

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

Sponsors & Collaborators

• Monash University: lead

Study Sites (4)

Box Hill Hospital

Box Hill, Victoria, Australia

Location

Caulfield General Medical Centre

Caulfield, Victoria, Australia

Location

The Northern Hospital

Epping, Victoria, Australia

Location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Related Links

• Centre for Clinical Research Excellence in Therapeutics
• Department of Epidemiology \& Preventive Medicine, Monash University

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Dipak Kotecha, MBChB MRCP

  Monash University

  PRINCIPAL INVESTIGATOR

• John Varigos, BSc

  Monash University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Lecturer

Study Record Dates

• First Submitted: July 2, 2007
• First Posted: July 3, 2007
• Study Start: August 1, 2007
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Locations

AU (4)