Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography (VIRDICT)
Coronary Artery Disease, Atheroscleroses, Coronary, Vascular Inflammation
About this trial
This is an interventional prevention trial for Coronary Artery Disease focused on measuring vascular inflammation, fat attenuation index, pericoronary adipose tissue, coronary computed tomography angiography
Eligibility Criteria
Inclusion Criteria: Participants must satisfy the following conditions: Male or female, aged 30 to 80 years CCTA scan showing mild coronary artery plaques (<50% luminal stenosis) and CaRi-Heart Risk ≥ 5% and/or FAI-Score ≥ 75th percentile in the left anterior coronary or right coronary artery or FAI-Score ≥ 95th percentile in the circumflex coronary within the last 6 months. Willing and able (in the Investigators opinion) to comply with all study requirements. Able to understand both verbal or written Greek No definite clinical indication for a change in treatment based on European Society of Cardiology guidelines or planned revascularization Exclusion Criteria: The participant may not enter the study if ANY of the following are known to apply: Previous documented history of coronary artery disease requiring treatment. This includes any of the following: i. Acute myocardial infarction ii. Unstable angina iii. Coronary revascularization procedure iv. Clinically significant coronary artery disease diagnosed by invasive or non-invasive testing. History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent. Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids) Active neoplasm requiring surgery, chemotherapy, or radiation within the prior 12 months (subjects with a history of malignancy who have undergone curative resection or otherwise not requiring treatment for at least 12 months prior to screening with no detectable recurrence are allowed) Contraindication for statin therapy. Patients with intolerance to colchicine therapy may be included but they will receive statin treatment only. Severe Chronic kidney disease (estimated glomerular filtration rate < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or 220 µmol/l). Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3 × the upper limit of normal [ULN] measured on local labs in last 6 months) Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study. Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks. Patients unable to understand verbal or written English. Contraindication to contract dye for CCTA. Pregnancy
Sites / Locations
- 1st Cardiology Department, Hippokration General Hospital of AthensRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of care management
Coronary inflammation-based management
Patients will receive standard of care treatment.
Participants classified as moderate risk (FAI-Score 75th-89th percentile for the RCA or the LAD or ≥ 95th percentile for the LCx) or CaRi-Heart risk≥ 5% and <10%) will receive atorvastatin 40mg daily, if they do not already receive statin therapy, while if they already receive statin, it will be discontinued and they will be given atorvastatin 80 mg daily. Participants classified as high risk (FAI-Score≥ 90th percentile for the RCA or the LAD or CaRi-Heart risk≥ 10%) will receive atorvastatin 80 mg daily and colchicine 0.5 mg daily. Tolerance and compliance will be monitored during the study follow-up and participants will be informed at enrollment about possible treatment side effects. In case of colchicine intolerance, colchicine will be discontinued. If the patient cannot tolerate atorvastatin, then half dose may be prescribed daily. In case of severe adverse events related to atorvastatin, atorvastatin will be discontinued and the participant will withdraw from the study.