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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00495456

Registration number

NCT00495456

Ethics application status

Date submitted

2/07/2007

Date registered

3/07/2007

Date last updated

13/04/2022

Titles & IDs

Public title

Cardiovascular Longitudinal Evaluation & Assessment of Risk (CLEAR) Study

Scientific title

Cardiovascular Longitudinal Evaluation & Assessment of Risk Study

Secondary ID [1]

CGMC 1-07 (CLEAR)

Universal Trial Number (UTN)

Trial acronym

CLEAR

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cardiovascular Disease

Condition category

Condition code

Intervention/exposure

Study type

Observational

Patient registry

Target follow-up duration

Target follow-up type

Description of intervention(s) / exposure

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

To assess risk factors for cardiovascular disease.

Timepoint [1]

Annually

Eligibility

Key inclusion criteria

* Patients above 18 years of age

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

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

Study design

Purpose

Duration

Selection

Timing

Prospective

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/08/2007

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/12/2021

Sample size

Target

Accrual to date

Final

665

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Box Hill Hospital - Box Hill

Recruitment hospital [2]

Caulfield General Medical Centre - Caulfield

Recruitment hospital [3]

The Northern Hospital - Epping

Recruitment hospital [4]

Alfred Hospital - Melbourne

Recruitment postcode(s) [1]

- Box Hill

Recruitment postcode(s) [2]

- Caulfield

Recruitment postcode(s) [3]

- Epping

Recruitment postcode(s) [4]

3004 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

Monash University

Address

Country

Ethics approval

Ethics application status

Summary

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.

Trial website

https://clinicaltrials.gov/study/NCT00495456

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dipak Kotecha, MBChB MRCP

Address

Monash University

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00495456

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00495456