Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Greece
1st Cardiology Department, Hippokration General Hospital of Athens
RECRUITING
Athens
Contact Information
Primary
Alexios S Antonopoulos, MD, PhD
antonopoulosal@yahoo.gr
+306947607442
Backup
Spyridon D Simantiris, MD
spyrsim@gmail.com
+306949402966
Time Frame
Start Date: 2022-01-22
Estimated Completion Date: 2025-07-22
Participants
Target number of participants: 140
Treatments
No_intervention: Standard of care management
Patients will receive standard of care treatment.
Experimental: Coronary inflammation-based management
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.
Related Therapeutic Areas
Sponsors
Leads: Hippocration General Hospital
Collaborators: Biomedical Research Foundation, Academy of Athens

This content was sourced from clinicaltrials.gov