RecruitingACTRN12618001322224

The BioHeart Study: assessing patients with suspected cardiovascular disease for new disease markers and risk factors

The BioHeart Study: biobanking for discovery of novel cardiovascular biomarkers and risk factors using unbiased omics and candidate approaches - a longitudinal, prospective, cohort study of patients with known or suspected cardiovascular disease

Sponsor

Northern Sydney Local Health District - Royal North Shore Hospital

Enrollment

5,000 participants

Start Date

Nov 16, 2015

Study Type

Observational

Conditions

Pericarditis Cardiomyopathy Myocarditis Aortic Stenosis

Summary

For many diseases, researchers have been able to find ‘biomarkers’ that are in the blood and that can predict whether or not someone is at risk of getting the disease. Biomarkers are naturally occurring molecules, genes, or other characteristics that help us to identify diseases and disease processes. The purpose of the research project is to use blood and tissue from people with susceptibility or resilience to cardiovascular disease (CVD), and to try and find new biomarkers that can identify risk of CVD at an early stage. In addition, we will investigate the use of biomarkers that we have already identified, and their ability to predict events and outcomes. We hope that by doing this, we will be able to: 1. Find out more about how and why CVD occurs 2. Find out more about the way that CVD progresses and affects different people 3. Find new biomarkers that will help us to work out if someone is at risk of CVD earlier 4. Find new treatments for CVD

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

Patients presenting to emergency department, cardiovascular outpatient clinics, for cardiovascular testing (e.g. CTCA) for investigation and management of suspected cardiovascular disease, or for surgery involving removal of redundant tissue containing vascular tissue.
Patients willing and able to provide informed consent

Exclusion Criteria3

Patients highly dependent on medical care and unable to provide informed consent
Patients unwilling or unable to participate in on-going follow-up
Patients unwilling or unable to provide informed consent

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Interventions

Patients presenting with cardiac disorders or for investigation of suspected cardiac disorders are invited to participate in the BioHEART study. Biological specimens (e.g., blood) and imaging data are collected and correlated with demographic and risk factor data. Samples are analysed with the purpose of developing biomarkers for prognostic use in cardiovascular disease. Follow-up is performed at one month and then annually for the life of the study, at a minimum of 5 years.