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DEFINITIONS
Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12622000452796
Ethics application status
Approved
Date submitted
2/03/2022
Date registered
23/03/2022
Date last updated
21/01/2024
Date data sharing statement initially provided
23/03/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
The SMuRFless Coronary Artery Disease (CAD) Registry: An observational study of the quality of care and risk factors in patients with CAD but without Standard Modifiable cardiovascular Risk Factors (SMuRFs)
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Scientific title
A Multi-centre, Prospective, Observational Cohort Study of Patients Attending the National Health & Medical Research Council (NHMRC) Centre for Research Excellence for Coronary Artery Disease without Standard Modifiable Cardiovascular Risk Factors
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Secondary ID [1]
306579
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
325476
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Condition category
Condition code
Cardiovascular
322860
322860
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0
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Coronary heart disease
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Intervention/exposure
Study type
Observational
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Patient registry
True
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Target follow-up duration
5
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Target follow-up type
Years
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Description of intervention(s) / exposure
Participants in the SMuRFless CAD Registry will complete a questionnaire at the time of enrolment either electronically on on paper, depending on his or her preference, which is expected to take approximately 15-20 minutes. In addition, information from the participant's SMuRFless CAD clinic visit will be recorded in the registry.
Participants will be invited to provide informed consent for Medicare Benefits Schedule (MBS) / Pharmaceutical Benefits Scheme (PBS) data linkage to assess outcomes at 5-years, including major adverse cardiovascular events (MACE) and changes in medications after the SMuRFless CAD clinic visit.
Participants who return to the SMuRFless CAD clinic for a clinically indicated visit will be invited to complete a questionnaire during this visit for the SMuRFless CAD Registry. This questionnaire can also be completed electronically or by paper form and is expected to take approximately 5-10 minutes.
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Intervention code [1]
323009
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Diagnosis / Prognosis
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Comparator / control treatment
None
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
330640
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To measure utilisation of the NHMRC Centre for Research Excellence in CAD clinical pathway by pathway tests completed for the participant in the clinic setting.
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Assessment method [1]
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Timepoint [1]
330640
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Assessed at the time of enrolment for up to 5-years
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Primary outcome [2]
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To measure results of tests included in the NHMRC Centre for Research Excellence in CAD clinical pathway
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Assessment method [2]
330743
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Timepoint [2]
330743
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Assessed at the time of enrolment
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Secondary outcome [1]
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Cost effectiveness of the NHMRC CRE clinical pathway in identifying risk factors of CAD progression by Medicare Benefits Schedule (MBS) / Pharmaceutical Benefits Scheme (PBS) data linkage.
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Assessment method [1]
407059
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Timepoint [1]
407059
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Assessed at the time of enrolment and 5 years post-enrolment
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Secondary outcome [2]
407185
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Rate of major adverse cardiovascular events (MACE) utilising MBS data linkage
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Assessment method [2]
407185
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Timepoint [2]
407185
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5 years post-enrolment
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Eligibility
Key inclusion criteria
• 18 years of age or older
• A clinically indicated visit to an NHMRC CRE for CAD clinic
• Diagnosed or suspected atherosclerotic coronary artery disease (CAD), based on invasive coronary angiography or CT coronary angiography findings, or a family member of an individual with diagnosed CAD
• Willing and able to provide informed consent by self
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Prior medical diagnosis of hypertension
• Prior medical diagnosis of hyperlipidaemia
• Prior medical diagnosis of diabetes mellitus
• History of tobacco smoking within the past 12 months
• Patients highly dependent on medical care and unable to provide informed consent
• People with cognitive impairment, intellectual disability, or mental illness that prevent them from providing informed consent for themselves
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/06/2022
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Actual
29/07/2022
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Date of last participant enrolment
Anticipated
29/05/2026
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Actual
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Date of last data collection
Anticipated
31/12/2031
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Actual
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Sample size
Target
1000
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
21864
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Royal North Shore Hospital - St Leonards
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Recruitment hospital [2]
26049
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The Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
36927
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2065 - Royal North Shore Hospital
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Recruitment postcode(s) [2]
36928
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2065 - St Leonards
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Recruitment postcode(s) [3]
41901
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5000 - Adelaide
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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National Health and Medical Research Council (NHMRC) Centres of Research Excellence Grant (GNT1196629)
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Address [1]
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Kolling Institute of Medical Research, Level 12, Royal North Shore Hospital, Reserve Road, St Leonards NSW 2065
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Country [1]
310910
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
Level 3, Michael Spence Building (F23)
University of Sydney
Camperdown NSW 2006
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
312197
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None
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Address [1]
312197
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None
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Country [1]
312197
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
310472
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Northern Sydney Local Health District
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Ethics committee address [1]
310472
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Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
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Ethics committee country [1]
310472
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Australia
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Date submitted for ethics approval [1]
310472
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03/02/2022
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Approval date [1]
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15/04/2022
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Ethics approval number [1]
310472
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Summary
Brief summary
The SMuRFless CAD Registry is a study involving patients referred to an National Health & Medical Research Council (NHMRC) Centre for Research Excellence (CRE) for Coronary Artery Disease (CAD) clinic: a specialty clinic of patients with diagnosed or suspected atherosclerotic CAD. The SMuRFless CAD Registry seeks to measure and improve quality of care in SMuRFless CAD patients utilising traditional and applied data linkage methods for key longitudinal endpoints, to determine the clinical and cost effectiveness of the NHMRC CRE clinical pathway in identifying risk factors of CAD progression and to understand risk factors for outcomes and regional/centre differences.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Gemma A. Figtree
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Address
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Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
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Country
117786
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Australia
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Phone
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+61 0299267779
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Fax
117786
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Email
117786
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[email protected]
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Contact person for public queries
Name
117787
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Prof Gemma A. Figtree
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Address
117787
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Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
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Country
117787
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Australia
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Phone
117787
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+61 0299267779
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Fax
117787
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Email
117787
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[email protected]
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Contact person for scientific queries
Name
117788
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Prof Gemma A. Figtree
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Address
117788
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Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
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Country
117788
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Australia
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Phone
117788
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+61 0299267779
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Fax
117788
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Email
117788
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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