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

Plain Language Summary

Simplified for easier understanding

This study is a biobank and research registry for patients presenting to hospital with suspected or confirmed cardiovascular disease (CVD) — conditions affecting the heart and blood vessels, such as coronary artery disease, heart attack, and heart failure. The goal is to collect blood samples and sometimes small tissue samples (from routine surgeries) to search for new biological markers that can identify cardiovascular disease earlier or predict how it will progress. Participants are asked to donate a blood sample at the time of their clinic visit, procedure, or surgery. They are also followed up over time with additional blood draws and questionnaires. By building a collection of samples from people at different stages of cardiovascular health, researchers hope to discover new targets for earlier diagnosis and better treatments. You may be eligible if you are 18 or older and are attending Royal North Shore Hospital's emergency department or cardiovascular outpatient clinics for investigation of suspected cardiovascular disease, or are having a surgical procedure that removes tissue containing blood vessels. Patients who are unable to provide informed consent or who are unwilling to participate in ongoing follow-up are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.