ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001322224

Ethics application status

Approved

Date submitted

12/07/2018

Date registered

6/08/2018

Date last updated

14/07/2024

Date data sharing statement initially provided

10/07/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Coronary artery disease

Acute myocardial infarction

Cardiomyopathy

Myocarditis

Pericarditis

Aortic Stenosis

Condition category

Condition code

Cardiovascular

Coronary heart disease

Cardiovascular

Diseases of the vasculature and circulation including the lymphatic system

Cardiovascular

Other cardiovascular diseases

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

Target follow-up type

Years

Description of intervention(s) / exposure

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.

Intervention code [1]

Early Detection / Screening

Comparator / control treatment

No control group (observational study).

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Exploratory outcome of discovery of new biomarkers for coronary artery disease utilising unbiased genomics, transcriptomics, proteomics, metabolomics, lipidomics, and immunophenotyping techniques.

Timepoint [1]

Biological samples, clinical data and imaging data will be collected for each participant at time of recruitment. Discovery assays will be performed on batches of samples annually throughout the life of the study, for a minimum of five years.

Secondary outcome [1]

Determination of disease severity by analysis of imaging data with associated scoring of angiographic or computed tomography data utilising existing and novel scoring systems.

Timepoint [1]

Biological samples, clinical data and imaging data will be collected for each patient at time of recruitment. Imaging analysis will be performed on a weekly basis throughout the life of the study, for a minimum of five years.

Secondary outcome [2]

Determination of the rate of major cardiovascular adverse events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke) utilising follow-up phone calls and an adjudication panel to confirm events.

Timepoint [2]

Follow-up will be performed at three months and then annually for the life of the study.

Secondary outcome [3]

Determination of the rate of exploratory cardiovascular outcomes (revascularisation, hospitalised heart failure, hospitalised unstable angina) utilising follow-up phone calls and an adjudication panel to confirm events.

Timepoint [3]

Follow-up will be performed at three months and then annually for the life of the study.

Secondary outcome [4]

Assessment of soluble lectin-like oxidized low-density lipoprotein receptor-1 (sLOX-1) levels by serum ELISA assay and determination of the utility of this molecule as a biomarker.

Timepoint [4]

Biological samples, clinical data and imaging data will be collected for each patient at time of recruitment. Pilot assays will be performed on subgroups of the first 1000 patients, and if predictive, validation assays will be performed annually throughout the life of the study, for a minimum of five years.

Secondary outcome [5]

Assessment of hypercoagulable or hypofibrinolytic states as a composite endpoint as determined by the overall haemostatic potential assay and calibrated automated thrombogram assay in patients with unexplained cardiovascular disease.

Timepoint [5]

Secondary outcome [6]

Assessment for toxic levels of mercury by mass spectrometry of whole blood samples in patients with unexplained cardiovascular disease.

Timepoint [6]

Secondary outcome [7]

Assessment for toxic levels of cadmium by mass spectrometry of whole blood samples in patients with unexplained cardiovascular disease.

Timepoint [7]

Eligibility

Key inclusion criteria

- 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

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- 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

Study design

Purpose

Screening

Duration

Longitudinal

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

The sample size is estimated based on current referral patterns to the investigators’ departments/clinics. For the purposes of the biobank there are no specific statistical procedures. Sub-studies utilising tissue/data from the biobank and that are beyond the scope of the analyses outlined in this protocol will be submitted with relevant statistical plans as part of the ethics review process.

A risk model utilising existing and discovered biomarkers and outcome data from validation cohorts will be created to better explain cardiovascular risk profiles.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

Actual

16/11/2015

Date of last participant enrolment

Anticipated

10/01/2028

Actual

Date of last data collection

Anticipated

9/01/2033

Actual

Sample size

Target

5000

Accrual to date

4634

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,SA,VIC

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [3]

Concord Repatriation Hospital - Concord

Recruitment hospital [4]

Westmead Hospital - Westmead

Recruitment hospital [5]

North Shore Private Hospital - St Leonards

Recruitment hospital [6]

The Royal Adelaide Hospital - Adelaide

Recruitment hospital [7]

Victorian Heart Hospital - Clayton

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2050 - Camperdown

Recruitment postcode(s) [3]

2139 - Concord

Recruitment postcode(s) [4]

2145 - Westmead

Recruitment postcode(s) [5]

5000 - Adelaide

Recruitment postcode(s) [6]

3168 - Clayton

Recruitment postcode(s) [7]

4064 - Milton

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

North Shore Local Health District Cardiovascular Grant

Address [1]

51, Royal North Shore Hospital Campus, Reserve Rd, St Leonards NSW 2065

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Heart Foundation

Address [2]

80 William St, Woolloomooloo NSW 2011

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Ramsay Research Grant

Address [3]

154 Pacific Hwy, St Leonards NSW 2065

Country [3]

Australia

Funding source category [4]

Hospital

Name [4]

NSW Pathology

Address [4]

Royal North Shore Hospital Campus, Reserve Rd, St Leonards NSW 2065

Country [4]

Australia

Funding source category [5]

Government body

Name [5]

NHMRC Centre for Research Excellence (GNT1196629)

Address [5]

GPO Box 1421
Canberra ACT 2601

Country [5]

Australia

Primary sponsor type

Hospital

Name

Northern Sydney Local Health District - Royal North Shore Hospital

Address

51, Royal North Shore Hospital Campus, Reserve Rd, St Leonards NSW 2065

Country

Australia

Secondary sponsor category [1]

Hospital

Name [1]

Sydney Local Health District - Royal Prince Alfred Hospital

Address [1]

Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

Country [1]

Australia

Secondary sponsor category [2]

Hospital

Name [2]

Western Sydney Local Health District - Westmead Hospital

Address [2]

5 Fleet St, North Parramatta NSW 2151

Country [2]

Australia

Secondary sponsor category [3]

Hospital

Name [3]

North Shore Private Hospital

Address [3]

Westbourne St, St Leonards NSW 2065

Country [3]

Australia

Secondary sponsor category [4]

Hospital

Name [4]

Sydney Local Health District - Concord Hospital

Address [4]

Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050

Country [4]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee (EC00112)

Ethics committee address [1]

Level 13, Kolling Building, St Leonards, NSW, 2065

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

09/10/2017

Approval date [1]

18/12/2017

Ethics approval number [1]

2019/ETH08376

Ethics committee name [2]

Northern Sydney Local Health District Human Research Ethics Committee (EC00112)

Ethics committee address [2]

Level 13, Kolling Building, St Leonards, NSW, 2065

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

21/07/2015

Approval date [2]

30/10/2015

Ethics approval number [2]

LNR/15/HAWKE/302

Summary

Brief 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

Trial website

Trial related presentations / publications

Public notes

Additional assays to explore candidate biomarkers and risk factors in this cardiovascular cohort will be added as they are identified, pending relevant approvals.

Contacts

Principal investigator

Name

Prof Gemma Figtree

Address

Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065

Country

Australia

Phone

+61 02 9926 4915

Fax

+61 02 9926 4020

[email protected]

Contact person for public queries

Name

Gemma Figtree

Address

Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065

Country

Australia

Phone

+61 02 9926 4915

Fax

+61 02 9926 4020

[email protected]

Contact person for scientific queries

Name

Gemma Figtree

Address

Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065

Country

Australia

Phone

+61 02 9926 4915

Fax

+61 02 9926 4020

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Sharing of individual data in this manner is not included in the ethics for the study.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11198	Study protocol	Kott KA, Vernon ST, Hansen T, et al. Biobanking for discovery of novel cardiovascular biomarkers using imaging-quantified disease burden: protocol for the longitudinal, prospective, BioHEART-CT cohort study. BMJ Open 2019;9:e028649. doi:10.1136/bmjopen-2018-028649	https://pubmed.ncbi.nlm.nih.gov/31537558

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Biobanking for discovery of novel cardiovascular biomarkers using imaging-quantified disease burden: Protocol for the longitudinal, prospective, BioHEART-CT cohort study.	2019	https://dx.doi.org/10.1136/bmjopen-2018-028649
Embase	Association of global coagulation profiles with cardiovascular risk factors and atherosclerosis: A sex disaggregated analysis from the bioheart-ct study.	2021	https://dx.doi.org/10.1161/JAHA.120.020604
Embase	Coronary artery disease burden in women poorly explained by traditional risk factors: Sex disaggregated analyses from the BioHEART-CT study.	2021	https://dx.doi.org/10.1016/j.atherosclerosis.2021.05.004
Embase	Metabolic signatures in coronary artery disease: Results from the bioHEART-CT study.	2021	https://dx.doi.org/10.3390/cells10050980
Dimensions AI	ß 3 Adrenergic Receptor Stimulation Promotes Reperfusion in Ischemic Limbs in a Murine Diabetic Model	2021	https://doi.org/10.3389/fphar.2021.666334
Embase	Immunoglobulin e Sensitization to Mammalian Oligosaccharide Galactose-alpha-1,3 (alpha-Gal) Is Associated with Noncalcified Plaque, Obstructive Coronary Artery Disease, and ST-Segment-Elevated Myocardial Infarction.	2022	https://dx.doi.org/10.1161/ATVBAHA.121.316878
Embase	Clinical Pathway for Coronary Atherosclerosis in Patients Without Conventional Modifiable Risk Factors: JACC State-of-the-Art Review.	2023	https://dx.doi.org/10.1016/j.jacc.2023.06.045
Embase	Lipidomics Profiling and Risk of Coronary Artery Disease in the BioHEART-CT Discovery Cohort.	2023	https://dx.doi.org/10.3390/biom13060917

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically