Status:
UNKNOWN
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
Lead Sponsor:
University of Sao Paulo General Hospital
Conditions:
Atherosclerosis
Inflammatory Response
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
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 corona...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 7 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05347316
Start Date
March 7 2022
End Date
March 7 2025
Last Update
May 9 2022
Active Locations (1)
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1
Heart Institute - University of São Paulo
São Paulo, São Paulo, Brazil, 05403000