The “New predictiVe factors that drIve coronary atheroscleroSIs follOwiNg Coronary Artery Disease (VISION-CAD)” study
South Australian Health and Medical Research Institute
300 participants
May 5, 2023
Observational
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria10
- 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
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Interventions
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.
Locations(3)
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ACTRN12623000458639