Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

Launched by HIPPOCRATION GENERAL HOSPITAL · Oct 11, 2023

Keywords

ClinConnect Summary

This clinical trial is looking to find out if a new treatment plan, called CaRi-Heart, is better at reducing inflammation in blood vessels compared to standard care for patients with coronary artery disease. The main focus is on patients who have a higher score related to fat around their blood vessels, which can indicate inflammation. Participants in the study will be randomly assigned to either continue with standard treatment or receive the intensified CaRi-Heart treatment, which includes a higher dose of a cholesterol-lowering medication and possibly a low dose of another drug. They will be monitored closely for six months, with regular blood tests and imaging to measure changes in inflammation.

To be eligible for this trial, participants need to be between 30 and 80 years old, have mild coronary artery plaques, and meet specific risk score criteria. They should be able to understand Greek and not have any serious heart conditions or other illnesses that might complicate their ability to participate. Throughout the study, participants will undergo tests to see how well the treatments work and to ensure their safety. This trial is currently recruiting participants, and being part of it could help improve treatments for coronary artery disease in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Participants must satisfy the following conditions:
• • 1. Male or female, aged 30 to 80 years
• • 2. 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.
• • 3. Willing and able (in the Investigators opinion) to comply with all study requirements.
• • 4. Able to understand both verbal or written Greek
• • 5. 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:
• 1. 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.
• • 2. History of New York Heart Association (NYHA) Class III or IV heart failure within the past 12 months of consent.
• • 3. Autoimmune disease requiring immunosuppressive therapy or systemic corticosteroid therapy
• • 4. Active chronic treatment with any anti-inflammatory agents (e.g. NSAIDs, systemic corticosteroids)
• • 5. 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)
• • 6. Contraindication for statin therapy. Patients with intolerance to colchicine therapy may be included but they will receive statin treatment only.
• • 7. 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).
• • 8. Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3 × the upper limit of normal \[ULN\] measured on local labs in last 6 months)
• • 9. Any clinically significant abnormality identified at the time of screening that, in the opinion of the Investigator, would preclude safe completion of the study.
• • 10. 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.
• • 11. Participants who have participated in another research study involving a treatment intervention or an investigational product, in the past 12 weeks.
• • 12. Patients unable to understand verbal or written English.
• • 13. Contraindication to contract dye for CCTA.
• • 14. Pregnancy