Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000400561
Ethics application status
Approved
Date submitted
26/02/2024
Date registered
3/04/2024
Date last updated
25/04/2024
Date data sharing statement initially provided
3/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Coronary Artery disease SCreening in young ADult relativEs of individuals with premature Myocardial Infarction (CASCADE-MI study)
Scientific title
Coronary Artery disease SCreening in young ADult relativEs of individuals with premature Myocardial Infarction (CASCADE-MI study)
Secondary ID [1] 311605 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Myocardial infarction 333021 0
Coronary artery disease 333022 0
Risk factors 333023 0
Condition category
Condition code
Cardiovascular 329709 329709 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
CT coronary angiography plus routine cardiovascular risk factor assessment.
- CT coronary angiography will be performed at an accredited centre and typically will involve less than 1 hour of the participant's time. An intravenous cannula will be required for iodinated contrast to be administered during the scan.
- The routine cardiovascular risk factor assessment will be performed over 15-30 minutes clinic by a Cardiologist and will involve a clinical assessment of risk factors, medications, physical exam findings, blood tests and calculation of risk using the Australian CVD risk calculator.
Intervention code [1] 328059 0
Early detection / Screening
Comparator / control treatment
Routine cardiovascular risk factor assessment
- The routine cardiovascular risk factor assessment will be performed over 15-30 minutes clinic by a Cardiologist and will involve a clinical assessment of risk factors, medications, physical exam findings, blood tests and calculation of risk using the Australian CVD risk calculator.
Control group
Active

Outcomes
Primary outcome [1] 337506 0
Difference in low-density lipoprotein cholesterol (LDL-C) level at 1 year between the two arms
Timepoint [1] 337506 0
1 year follow-up
Secondary outcome [1] 432141 0
Cardiovascular risk factor profile in adult family members of individuals with premature MI.
Timepoint [1] 432141 0
Baseline (at single screening assessment)
Secondary outcome [2] 432142 0
Difference in use of preventive medications (i.e., statins) between two arms.
Timepoint [2] 432142 0
3 months and 1 year post-screening
Secondary outcome [3] 432143 0
Differences in adherence to healthy lifestyle between two arms.
Timepoint [3] 432143 0
3 months and 1 year post-screening
Secondary outcome [4] 432751 0
Cost-effectiveness of computed tomography coronary angiography for screening in this cohort.
Timepoint [4] 432751 0
1 year post-screening
Secondary outcome [5] 433323 0
Burden of coronary artery disease on computed tomography coronary angiography in adult family members of individuals with premature MI.
Timepoint [5] 433323 0
Baseline (at single screening assessment)

Eligibility
Key inclusion criteria
Apparently healthy first-degree relative aged 30 to 55 years of a patient with myocardial infarction at premature age (<55 years).
Minimum age
30 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for the apparently healthy relative will include:
• History of cardiovascular disease (i.e., coronary artery disease, peripheral arterial disease, or cerebrovascular disease).
• Already taking aspirin or statin.
• History of iodinated contrast allergy/anaphylaxis.
• Known renal impairment with estimated glomerular filtration rate <45 ml/min/1.73m2.
• Unwilling or unable to provide informed consent.
• Pregnant women.

Exclusion criteria for the index case (patient) will include the following diagnoses:
• Non-atherosclerotic cause of myocardial infarction such as spontaneous coronary artery dissection, paradoxical venous thrombo-embolism, myocarditis, pericarditis, vasospasm, and Takotsubo cardiomyopathy.
• Myocardial infarction with nonobstructive coronary arteries.
• Probable or definite familial hypercholesterolaemia by the Dutch Lipid Clinic Network Criteria (score 6 or more).
• Age <18 years.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be performed through central randomisation by a computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be performed by computer software, accounting for the cluster randomised design where family members will be randomised to the same arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315913 0
Government body
Name [1] 315913 0
South Metropolitan Health Service
Country [1] 315913 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Country
Australia
Secondary sponsor category [1] 318063 0
None
Name [1] 318063 0
Address [1] 318063 0
Country [1] 318063 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314759 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 314759 0
Ethics committee country [1] 314759 0
Australia
Date submitted for ethics approval [1] 314759 0
23/01/2024
Approval date [1] 314759 0
21/03/2024
Ethics approval number [1] 314759 0

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

Contacts
Principal investigator
Name 132634 0
Dr Abdul Rahman Ihdayhid
Address 132634 0
Fiona Stanley Hospital - 11 Robin Warren Drive, Murdoch WA 6155
Country 132634 0
Australia
Phone 132634 0
+61 8 61511246
Fax 132634 0
Email 132634 0
[email protected]
Contact person for public queries
Name 132635 0
Nick Lan
Address 132635 0
Fiona Stanley Hospital - 11 Robin Warren Drive, Murdoch WA 6155
Country 132635 0
Australia
Phone 132635 0
+61 8 61511246
Fax 132635 0
Email 132635 0
[email protected]
Contact person for scientific queries
Name 132636 0
Nick Lan
Address 132636 0
Fiona Stanley Hospital - 11 Robin Warren Drive, Murdoch WA 6155
Country 132636 0
Australia
Phone 132636 0
+61 8 61511246
Fax 132636 0
Email 132636 0
[email protected]

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.