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

Not Applicable

Recruiting

• Conditions: Coronary artery disease; Atherosclerosis; Ischaemic heart disease; Cardiovascular; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Cardiovascular - Coronary heart disease

• Registration Number: ACTRN12623000458639
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-03
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

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.

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

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in coronary plaque characteristics including progression via CT coronary angiography[ 12 months post-enrolment];Changes in the glycome via mass spectometry of blood samples. [ 12 months post-enrolment];Primary composite outcome of major cardiovascular outcomes - mortality, myocardial infarction, cardiac death, revascularisation, stroke, cardiovascular hospitalisation.<br>Via review of medical records, telephone interview, and interview in-person visit at 12 months for second CT scan. [ 12 months post enrolment. ]

Secondary Outcome Measures

Name	Time	Method
Quality of life (EQ-5D-3L) questionnaire[ At enrolment and 12 months post-enrolment ];Angina questionnaire - SAQ-7[ At enrolment and 12 months post-enrolment ];Coronary plaque volume via CT coronary angiography with automated software or manual plaque analysis [ 12 months post-enrolment ]