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
14/07/2024
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)
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
Secondary ID [1] 306579 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease 325476 0
Condition category
Condition code
Cardiovascular 322860 322860 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
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.
Intervention code [1] 323009 0
Diagnosis / Prognosis
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330640 0
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.
Timepoint [1] 330640 0
Assessed at the time of enrolment for up to 5-years
Primary outcome [2] 330743 0
To measure results of tests included in the NHMRC Centre for Research Excellence in CAD clinical pathway
Timepoint [2] 330743 0
Assessed at the time of enrolment
Secondary outcome [1] 407059 0
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.
Timepoint [1] 407059 0
Assessed at the time of enrolment and 5 years post-enrolment
Secondary outcome [2] 407185 0
Rate of major adverse cardiovascular events (MACE) utilising MBS data linkage
Timepoint [2] 407185 0
5 years post-enrolment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
29/07/2022
Date of last participant enrolment
Anticipated
29/05/2026
Actual
Date of last data collection
Anticipated
31/12/2031
Actual
Sample size
Target
1000
Accrual to date
24
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 21864 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 26049 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 36927 0
2065 - Royal North Shore Hospital
Recruitment postcode(s) [2] 36928 0
2065 - St Leonards
Recruitment postcode(s) [3] 41901 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 310910 0
Government body
Name [1] 310910 0
National Health and Medical Research Council (NHMRC) Centres of Research Excellence Grant (GNT1196629)
Country [1] 310910 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Level 3, Michael Spence Building (F23)
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 312197 0
None
Name [1] 312197 0
None
Address [1] 312197 0
None
Country [1] 312197 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310472 0
Northern Sydney Local Health District
Ethics committee address [1] 310472 0
Ethics committee country [1] 310472 0
Australia
Date submitted for ethics approval [1] 310472 0
03/02/2022
Approval date [1] 310472 0
15/04/2022
Ethics approval number [1] 310472 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117786 0
Prof Gemma A. Figtree
Address 117786 0
Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
Country 117786 0
Australia
Phone 117786 0
+61 0299267779
Fax 117786 0
Email 117786 0
gemma.figtree@sydney.edu.au
Contact person for public queries
Name 117787 0
Gemma A. Figtree
Address 117787 0
Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
Country 117787 0
Australia
Phone 117787 0
+61 0299267779
Fax 117787 0
Email 117787 0
gemma.figtree@sydney.edu.au
Contact person for scientific queries
Name 117788 0
Gemma A. Figtree
Address 117788 0
Sydney Medical School (Northern)
Cardiology Department, Royal North Shore Hospital Reserve Road, St Leonards NSW 2065 Australia
Country 117788 0
Australia
Phone 117788 0
+61 0299267779
Fax 117788 0
Email 117788 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


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.