Atherosclerosis, Coronary Disease, Inflammatory Response
Conditions
Keywords
Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation
Brief summary
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.
Detailed description
A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.
Interventions
DRUGColchicine
0.5 mg per day colchicine for 12 months
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals of both sexes over 18 years of age; * Patients undergoing coronary CT angiography from May/2021 * CT angiography showing non-calcified or mixed coronary plaques and high FAI value (\> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with * Willing and able (in the opinion of the investigators) to fulfill all study requirements
Exclusion criteria
* Past history of acute myocardial infarction * History of percutaneous or surgical myocardial revascularization * History of previous cardiac surgery or congenital heart disease * Current use of colchicine * Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy * Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed) * Inflammatory bowel disease or chronic diarrhea * Clinically significant non-transient hematologic abnormalities * Renal dysfunction (GFR \< 30 mL/min/1.73 m² and/or serum creatinine \> 2.5 mg/dL or \< 220 µmol/l) * Severe liver disease (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \> 3x ULN in the last 6 months) * Drug addiction or alcoholism * History of clinically significant sensitivity to colchicine * Inability to sign the informed consent form * Participation in another study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of FAI in both groups after 12-month follow-up | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of low attenuation plate volume variation; | 12 months |
| Occurrence of general death | 12 months |
| Occurrence of cardiovascular death | 12 months |
| Evaluation of the variation total atheroma volume | 12 months |
| Occurrence of stroke | 12 months |
| Occurrence of need for myocardial revascularization | 12 months |
| Occurrence of acute myocardial infarction | 12 months |
Countries
Brazil
Contacts
Primary ContactCARLOS SERRANO, Doctor
Backup ContactCamila Barbosa, Doctor
Outcome results
None listed