RecruitingACTRN12623000458639

The “New predictiVe factors that drIve coronary atheroscleroSIs follOwiNg Coronary Artery Disease (VISION-CAD)” study

Sponsor

South Australian Health and Medical Research Institute

Enrollment

300 participants

Start Date

May 5, 2023

Study Type

Observational

Conditions

Atherosclerosis Cardiovascular Ischaemic heart disease

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Coronary artery disease (CAD) happens when plaques — made of fat, cholesterol, and other substances — build up inside the arteries that supply the heart with blood. Even when patients are on the best available medications, some plaques continue to grow or become unstable, which can lead to heart attacks. But researchers don't fully understand all the reasons why this happens. The VISION-CAD study is an observational study following people who have had a coronary angiogram (a special X-ray of the heart's arteries) at Adelaide hospitals. If you have some residual plaque that won't be treated surgically right away, the study team will take a CT scan of your heart arteries, collect blood and stool samples, and repeat everything 12 months later. This lets researchers compare how plaques change over time and look for biological clues — including gut bacteria — that might explain why some plaques progress and others don't. You may be eligible if you are 18 or older, have had a coronary angiogram showing plaque that will be monitored rather than immediately treated, and are able to attend follow-up visits. People on dialysis or with previous bypass surgery are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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.