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Vascular Inflammation ReDuction and Perivascular Fat Imaging by Computed Tomography

NCT06083337 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2023-10-16

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CaRi-Heart device

Open-label treatment with atorvastatin +/- low-dose colchicine medications based on CaRi-Heart algorithm management.

Sponsors & Collaborators

  • Biomedical Research Foundation, Academy of Athens

    collaborator OTHER

  • Hippocration General Hospital

    lead OTHER

Principal Investigators

  • Alexios S Antonopoulos, MD, PhD · 1st Cardiology Department, Hippokration General Hospital of Athens

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-22
Primary Completion
2025-07-22
Completion
2025-07-22

Countries

  • Greece

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06083337 on ClinicalTrials.gov