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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | 0.5 mg of colchicine daily for 12 months |
|
| Placebo | No Intervention | Follow-up for 12 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colchicine | Drug | 0.5 mg per day colchicine for 12 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of FAI in both groups after 12-month follow-up | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the variation total atheroma volume | 12 months | |
| Evaluation of low attenuation plate volume variation; | 12 months | |
| Occurrence of general death |
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Inclusion Criteria:
Exclusion Criteria:
over 18 years
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| CARLOS SERRANO, Doctor | Contact | +55(11) 26615447 | cvserranojr@gmail.com | |
| Camila Barbosa, Doctor | Contact | +55(11) 986015021 | dracamilatalita@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Institute - University of São Paulo | Recruiting | São Paulo | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D003327 | Coronary Disease |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| 12 months |
| Occurrence of cardiovascular death | 12 months |
| Occurrence of acute myocardial infarction | 12 months |
| Occurrence of stroke | 12 months |
| Occurrence of need for myocardial revascularization | 12 months |
| D017202 |
| Myocardial Ischemia |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |