NCT06083337

Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Hippocration General Hospital · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the effect of standard of care management vs. CaRi-Heart based management on vascular inflammation in patients with increased Fat Attenuation Index-Score. The main questions it aims to answer are: * Does treatment intensification reduce vascular inflammation detected by perivascular fat imaging to a greater extent than standard of care treatment? * Do changes in vascular inflammation biomarkers correlate with changes in lipid metrics or inflammatory biomarkers, such as interleukin-6? Participants will be randomized either to standard of care treatment or intensified treatment with maximum dose of atorvastatin +/- low dose of colchicine. After their inclusion, study participants will be followed-up for 6 months with regular monitoring for adverse events and blood will be drawn at 3 and 6 months. After the 6-month follow-up, participants will undergo CCTA imaging for fat attenuation index measurements. Researchers will compare standard of care and vascular inflammation-based treatment to see if inflammation-based treatment is more potent against vascular inflammation.

Detailed description

The VIRDICT study is a randomized, open-label clinical study including participants aged 30-80 years old, who underwent coronary computed tomography angiography (CCTA) and had no obstructive coronary stenoses. CCTA images will be transferred as pseudonymized DICOM data to Caristo Diagnostics Ltd for perivascular fat analysis. Individuals with evidence of coronary inflammation, as assessed by fat attenuation index (FAI) will be eligible for the VIRDICT study. Participants will be randomized either to standard of care treatment or inflammation-based treatment with atorvastatin ± colchicine. Participants will be followed-up for 6 months post randomization, with four follow-up visits (two by telephone call and two by onsite visit). At the end of their follow-up, participants will undergo a second CCTA and the relevant images will be analyzed for pericoronary inflammation. 140 participants are expected be included in the study. Interim analyses will be performed after sufficient patients (approximately 80 patients) have completed 24 weeks of follow-up. This is a pilot study to establish the ability of CCTA-derived FAI quantification to detect a change in coronary artery inflammation, following a period of treatment with medications with known anti-inflammatory properties (statin and colchicine).

Conditions

• Coronary Artery Disease
• Atheroscleroses, Coronary
• Vascular Inflammation

Interventions

Type	Name	Description
DEVICE	CaRi-Heart device	Open-label treatment with atorvastatin +/- low-dose colchicine medications based on CaRi-Heart algorithm management.

Timeline

• Start date: 2022-01-22
• Primary completion: 2025-07-22
• Completion: 2025-07-22
• First posted: 2023-10-16
• Last updated: 2023-10-16

Locations

1 site across 1 country: Greece