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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
10/07/2019
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] 295534 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 308798 0
Acute myocardial infarction 309011 0
Cardiomyopathy 309012 0
Myocarditis 309013 0
Pericarditis 309014 0
Condition category
Condition code
Cardiovascular 307733 307733 0 0
Coronary heart disease
Cardiovascular 307734 307734 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 307912 307912 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
Patients presenting with cardiac disorders or for investigation of suspected cardiac disorders are recruited and biological specimens 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] 301839 0
Early Detection / Screening
Comparator / control treatment
No control group (observational study).
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306721 0
Exploratory outcome of discovery of new biomarkers for coronary artery disease utilising unbiased proteomics, metabolomics, genomics and immunophenotyping techniques.
Timepoint [1] 306721 0
Biological samples, clinical data and imaging data will be collected for each patient 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] 349345 0
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] 349345 0
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] 350016 0
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] 350016 0
Follow-up will be performed at three months and then annually for the life of the study.
Secondary outcome [3] 350017 0
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] 350017 0
Follow-up will be performed at three months and then annually for the life of the study.
Secondary outcome [4] 350262 0
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] 350262 0
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] 350263 0
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] 350263 0
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 [6] 350264 0
Assessment for toxic levels of mercury by mass spectrometry of whole blood samples in patients with unexplained cardiovascular disease.
Timepoint [6] 350264 0
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 [7] 350355 0
Assessment for toxic levels of cadmium by mass spectrometry of whole blood samples in patients with unexplained cardiovascular disease.
Timepoint [7] 350355 0
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.

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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11427 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 11430 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 11431 0
Concord Repatriation Hospital - Concord
Recruitment hospital [4] 11432 0
Westmead Hospital - Westmead
Recruitment hospital [5] 11433 0
North Shore Private Hospital - St Leonards
Recruitment postcode(s) [1] 23434 0
2065 - St Leonards
Recruitment postcode(s) [2] 23437 0
2050 - Camperdown
Recruitment postcode(s) [3] 23438 0
2139 - Concord
Recruitment postcode(s) [4] 23439 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 300111 0
Hospital
Name [1] 300111 0
North Shore Local Health District Cardiovascular Grant
Address [1] 300111 0
51, Royal North Shore Hospital Campus, Reserve Rd, St Leonards NSW 2065
Country [1] 300111 0
Australia
Funding source category [2] 300112 0
Charities/Societies/Foundations
Name [2] 300112 0
Heart Foundation
Address [2] 300112 0
80 William St, Woolloomooloo NSW 2011
Country [2] 300112 0
Australia
Funding source category [3] 300113 0
Charities/Societies/Foundations
Name [3] 300113 0
Ramsay Research Grant
Address [3] 300113 0
154 Pacific Hwy, St Leonards NSW 2065
Country [3] 300113 0
Australia
Funding source category [4] 300114 0
Hospital
Name [4] 300114 0
NSW Pathology
Address [4] 300114 0
Royal North Shore Hospital Campus, Reserve Rd, St Leonards NSW 2065
Country [4] 300114 0
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] 299511 0
Hospital
Name [1] 299511 0
Sydney Local Health District - Royal Prince Alfred Hospital
Address [1] 299511 0
Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Country [1] 299511 0
Australia
Secondary sponsor category [2] 299512 0
Hospital
Name [2] 299512 0
Western Sydney Local Health District - Westmead Hospital
Address [2] 299512 0
5 Fleet St, North Parramatta NSW 2151
Country [2] 299512 0
Australia
Secondary sponsor category [3] 299513 0
Hospital
Name [3] 299513 0
North Shore Private Hospital
Address [3] 299513 0
Westbourne St, St Leonards NSW 2065
Country [3] 299513 0
Australia
Secondary sponsor category [4] 299736 0
Hospital
Name [4] 299736 0
Sydney Local Health District - Concord Hospital
Address [4] 299736 0
Level 11, KGV Building Missenden Road CAMPERDOWN NSW 2050
Country [4] 299736 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300953 0
Northern Sydney Local Health District Human Research Ethics Committee (EC00112)
Ethics committee address [1] 300953 0
Level 13, Kolling Building, St Leonards, NSW, 2065
Ethics committee country [1] 300953 0
Australia
Date submitted for ethics approval [1] 300953 0
09/10/2017
Approval date [1] 300953 0
18/12/2017
Ethics approval number [1] 300953 0
HREC/17/HAWKE/343
Ethics committee name [2] 300954 0
Northern Sydney Local Health District Human Research Ethics Committee (EC00112)
Ethics committee address [2] 300954 0
Level 13, Kolling Building, St Leonards, NSW, 2065
Ethics committee country [2] 300954 0
Australia
Date submitted for ethics approval [2] 300954 0
21/07/2015
Approval date [2] 300954 0
30/10/2015
Ethics approval number [2] 300954 0
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 85398 0
Prof Gemma Figtree
Address 85398 0
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 85398 0
Australia
Phone 85398 0
+61 02 9926 4915
Fax 85398 0
+61 02 9926 4020
Email 85398 0
gemma.figtree@sydney.edu.au
Contact person for public queries
Name 85399 0
Prof Gemma Figtree
Address 85399 0
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 85399 0
Australia
Phone 85399 0
+61 02 9926 4915
Fax 85399 0
+61 02 9926 4020
Email 85399 0
gemma.figtree@sydney.edu.au
Contact person for scientific queries
Name 85400 0
Prof Gemma Figtree
Address 85400 0
Level 12, Kolling Institute of Medical Research, Royal North Shore Hospital, Pacific Hwy, St Leonards NSW 2065
Country 85400 0
Australia
Phone 85400 0
+61 02 9926 4915
Fax 85400 0
+61 02 9926 4020
Email 85400 0
gemma.figtree@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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?
No other documents available
Summary results
No Results