Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Monash University
Sponsor:
Information provided by (Responsible Party):
Prof Henry Krum, Monash University
ClinicalTrials.gov Identifier:
NCT00495456
First received: July 2, 2007
Last updated: March 6, 2014
Last verified: March 2014
  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

Further study details as provided by Monash University:

Primary Outcome Measures:
  • To assess risk factors for cardiovascular disease. [ Time Frame: Annually ] [ Designated as safety issue: No ]

Estimated Enrollment: 999999
Study Start Date: August 2007
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Patients above 18 years of age

Exclusion Criteria:

  • Risk assessment would constitute harm to patient
  • Informed consent not obtainable
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00495456

Contacts
Contact: Chris Reid, BA DipEd MSc PhD +61399030752 Chris.Reid@med.monash.edu.au

Locations
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         
Sponsors and Collaborators
Monash University
Investigators
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 6, 2014
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 July 26, 2014