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Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study (CLEAR)

This study is currently recruiting participants.
Verified September 2017 by Ingrid Hopper, Monash University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00495456
First Posted: July 3, 2007
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Ingrid Hopper, Monash University
  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 Ingrid Hopper, Monash University:

Primary Outcome Measures:
  • To assess risk factors for cardiovascular disease. [ Time Frame: Annually ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Ingrid Hopper, Senior Lecturer, Monash University
ClinicalTrials.gov Identifier: NCT00495456     History of Changes
Other Study ID Numbers: CGMC 1-07 (CLEAR)
First Submitted: July 2, 2007
First Posted: July 3, 2007
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by Ingrid Hopper, Monash University:
cardiovascular
risk
longitudinal
prospective

Additional relevant MeSH terms:
Cardiovascular Diseases