Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000458639
Ethics application status
Approved
Date submitted
14/04/2023
Date registered
3/05/2023
Date last updated
21/05/2024
Date data sharing statement initially provided
3/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The “New predictiVe factors that drIve coronary atheroscleroSIs follOwiNg Coronary Artery Disease (VISION-CAD)” study
Scientific title
The “New predictiVe factors that drIve coronary atheroscleroSIs follOwiNg Coronary Artery Disease (VISION-CAD)” study
Secondary ID [1] 309461 0
nil
Universal Trial Number (UTN)
U1111-1283-4500
Trial acronym
VISION-CAD
Linked study record
nil

Health condition
Health condition(s) or problem(s) studied:
Coronary artery disease 329715 0
Atherosclerosis 329716 0
Ischaemic heart disease 329717 0
Cardiovascular 329770 0
Condition category
Condition code
Cardiovascular 326613 326613 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 326736 326736 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation via serial CT coronary angiography (CTCA) and body composition scans with clinical and biomarker correlation.
1. CT scans will take approximately 20mins. Intravenous CT contrast dye will be injected based on body-weight, up to a maximum of 70mL. The procedure will be conducted by a Cardiologist, Radiographer, Nurse and Radiologist. There will be a second CT scan at 12 months.
2. Body composition scans will take 3minutes and involve three 5mm axial slices, through liver and spleen, mid abdomen (4th lumbar vertebra) and mid-thigh, at first CT scan and 12month CT scan.
The participants will be asked to provide biological samples at enrolment (first CT scan) and at 12 months (second CT scan), which will involve 50mL blood sample and optional faecal specimen.
The participants will be asked to complete questionnaires (quality of life, angina, pain) which will take 15 minutes, at enrollment, 6 months (via phone call or electronically) and at 12 months. Participants may be followed up at 3 and 5 years for additional phone-calls for questionnaires. Time-points are relative to the time of the first CT scan.
The CT scans will be performed at SA Health and Medical Research Institute Clinical Research and Imaging Centre.
Intervention code [1] 325883 0
Diagnosis / Prognosis
Comparator / control treatment
Baseline CT scans will be collected as part of this study.
CT scans will be compared from baseline to CT scans at 12 months.
Control group
Active

Outcomes
Primary outcome [1] 334472 0
Change in coronary plaque characteristics including progression via CT coronary angiography
Timepoint [1] 334472 0
12 months post-enrolment
Primary outcome [2] 334473 0
Changes in the glycome via mass spectometry of blood samples.
Timepoint [2] 334473 0
12 months post-enrolment
Primary outcome [3] 334474 0
Primary composite outcome of major cardiovascular outcomes - mortality, myocardial infarction, cardiac death, revascularisation, stroke, cardiovascular hospitalisation.
Via review of medical records, telephone interview, and interview in-person visit at 12 months for second CT scan.
Timepoint [3] 334474 0
12 months post enrolment.
Secondary outcome [1] 420815 0
Quality of life (EQ-5D-3L) questionnaire
Timepoint [1] 420815 0
At enrolment and 12 months post-enrolment
Secondary outcome [2] 421049 0
Angina questionnaire - SAQ-7
Timepoint [2] 421049 0
At enrolment and 12 months post-enrolment
Secondary outcome [3] 421050 0
Coronary plaque volume via CT coronary angiography with automated software or manual plaque analysis
Timepoint [3] 421050 0
12 months post-enrolment

Eligibility
Key inclusion criteria
• Subjects who have received a clinically indicated coronary angiogram for stable or unstable CAD, including stable angina, unstable angina and acute myocardial infarction (MI), comprising non-ST elevation MI (NSTEMI) or ST-elevation MI (STEMI).
• All subjects will be managed as per their treating clinicians, including with percutaneous coronary intervention (PCI) where indicated and use of antiplatelets, lipid-lowering medication (e.g. statins) and other guideline-recommended therapies.
• Eligible subjects will be those who at the time of angiography are identified as having at least one major coronary artery system (left main, left anterior descending, left circumflex, ramus intermedius or right coronary artery) that will be left with residual coronary plaque with no intention to revascularise this by PCI or bypass grafting for at least the next 12 months. Age 18 years or more at the time of screening.
• Able to provide informed consent to undergo non-invasive CTCA imaging within 30 days of their index angiogram and return for a follow-up CTCA 12±1 months later.
• Willingness to provide a blood sample (50 mL) around the time of their baseline and follow-up CTCA, and attend for an additional face-to-face study visit or receive a phone call at 6 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any associated co-morbidity in which the life expectancy is <1 year.
• Dialysis or estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2
• Previous or planned coronary artery bypass grafting
• Active malignancy with ongoing or planned chemotherapy or radiation therapy
• Contraindications to CTCA
• Women of childbearing potential who are not partaking in contraception
• Unable to give informed consent
• Not willing or able to attend follow-up visits/repeat CTCA in 12 months
• Concurrent enrollment in a placebo-controlled trial or within 30 days of finishing a trial
• Any other information that the investigators consider will limit the ability of the participant to complete all study associated procedures and visits

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Linear and mixed regression models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/05/2023
Actual
5/05/2023
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
300
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 24534 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 24535 0
The Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 40126 0
5000 - Adelaide
Recruitment postcode(s) [2] 40127 0
5011 - Woodville

Funding & Sponsors
Funding source category [1] 313655 0
Government body
Name [1] 313655 0
Department of Health and Aged Care, MRFF Cardiovascular Mission
Country [1] 313655 0
Australia
Primary sponsor type
Other Collaborative groups
Name
South Australian Health and Medical Research Institute
Address
South Australian Health and Medical Research Institute
North Terrace, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 315449 0
None
Name [1] 315449 0
Address [1] 315449 0
Country [1] 315449 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312823 0
Central Adelaide Local Health Network (CALHN) Human Research Ethics Committee (HREC)
Ethics committee address [1] 312823 0
Royal Adelaide Hospital, Port Road, Adelaide SA 5000
Ethics committee country [1] 312823 0
Australia
Date submitted for ethics approval [1] 312823 0
17/01/2023
Approval date [1] 312823 0
16/02/2023
Ethics approval number [1] 312823 0

Summary
Brief summary

Hypothesis: In patients with coronary artery disease who are treated with guideline recommended therapies, ongoing progression and destabilisation of atherosclerotic plaques will be associated with previously unrecognised clinical, biological and mechanical factors that this prospective, natural history study seeks to identify.

Brief overview: This is a prospective, observational clinical study that will recruit participants undergoing clinically indicated coronary angiograms for stable or unstable symptoms at the Royal Adelaide and Queen Elizabeth Hospitals. All subjects will undergo guideline-recommended treatment of their coronary artery disease (CAD) at the direction of their treating clinicians. Eligible subjects will be those who have at least one major coronary artery system that will be left with residual coronary plaque. Following informed consent and within 30 days of their index angiogram, subjects will undergo further evaluation of their coronary plaque(s) by non-invasive computer tomography coronary angiography (CTCA), along with collection of clinical data and collection and storage of blood and faeces specimens (Baseline). They will return after 12±1 months for repeat CTCA imaging and collection of clinical information, blood and faeces (Follow-up).
We will assess for changes in coronary plaque burden and composition between baseline and follow-up CTCA scans, and examine for their associations with a range of established and exploratory clinical, biological and mechanical factors. An additional study visit will be conducted at 6 months to collect clinical information and conduct questionnaires related to quality-of-life, mental well-being and pain scores.
Aims/Objectives: To determine:
(1) Changes in noncalcified plaque volume between baseline and follow-up CTCA scans in patients with CAD.

(2) Changes in other CTCA-derived measures of coronary plaque burden and composition, between baseline and follow-up CTCA scans including: (i) total atheroma volume, (ii), calcified plaque volume, (iii) low attenuated plaque volume, (iv) percent atheroma volume, (v) maximum lumen stenosis, (vi) Leaman score, (vii) epicardial fat attenuation index and other (viii) novel plaque characteristics between baseline and 12-month follow-up.

(3) Changes in blood, urinary and faecal biomarkers of interest that may associate with the development and progression of atherosclerotic CAD, as well as associations with quality of life, mental well-being and the presence of cardiac and non-cardiac pain syndrome data.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126046 0
A/Prof Peter Psaltis
Address 126046 0
SAHMRI, North Terrace, Adelaide SA 5000
Country 126046 0
Australia
Phone 126046 0
+61 0882184000
Fax 126046 0
Email 126046 0
peter.psaltis@sahmri.com
Contact person for public queries
Name 126047 0
Dr Naomi Wattchow
Address 126047 0
SAHMRI, North Terrace, Adelaide SA 5000
Country 126047 0
Australia
Phone 126047 0
+61 437656853
Fax 126047 0
Email 126047 0
naomi.wattchow@sahmri.com
Contact person for scientific queries
Name 126048 0
Dr Naomi Wattchow
Address 126048 0
SAHMRI, North Terrace, Adelaide SA 5000
Country 126048 0
Australia
Phone 126048 0
+61 437656853
Fax 126048 0
Email 126048 0
naomi.wattchow@sahmri.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
pooled analysis of patient data will be studied


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.