Acute Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Inflammation, CRP, Colchicine
Brief summary
Background: Colchicine is an old well-known venerable drug routinely used in gout attacks for instance. More recnetly it is regularly use in the treatment of pericarditis. It couls exert antiiflammatory effects targeting the adverse inflammation occuring incase of acute myocardial infarction, which is involved in poor outcomes or longer stay at hospital. Endpoints: * Main endpoint: AUC CRP during the initial hospital stay * Secondary endpoints: * Clinical: oucomes * Imaging: ETT, MRI * Biological: various biomarkers Method Randomized, controled, open-labbelled, comparing two parallel arms: conventionnal optimal treatment versus conventionnal optimal treatment + colchicine
Interventions
DRUGColchimax®
DRUGConventional treatment
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Acute myocardial inflarction (occlusion of coronary artery as assessed on the coronaro angiogram) * Adult (18-90y) * Men / women * Aigned informed consent * Health insurance
Exclusion criteria
* Cardiogenic shock * Digestive troubles * Active bowels inflammatory disease (Crhon, chronic, diarrhea...) * Intolerance to the drug * Renal insufficiency clearance \< 30mL/min * Immunosuppression, aplasia * Active infectious disease, active known neoplasia, chronic inflammatory disease * Hypersensitivity, allergy to one of studies components * Active liver disease * Poor hemodynamic conditions * Recent severe sepsis * Chronic treatment with corticoids or no steroids antiinflammatory agents * No possibility for informed consent * Protected by the law * Poor abservance * History of toxicomania, suicice attempts * Pregnacy, breeding, project of pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC CRP | 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hospitalization time | 1 year | Clinical outcome |
| CRP measurement | 1 year | Intrahospital peak CPK (Biological outcome) |
| CPK measurement | 1 year | Size IDM (pic and kinetics) (Biological outcome) |
| Troponin-hs measurement | 1 year | Size IDM (pic and kinetics) (Biological outcome) |
| Drug tolerance | 1 year | Clinical outcome |
| measurement of left ventricular end-systolic volume | Day of inclusion and one month after inclusion | Remodeling ETT |
| measurement of left ventricular diastolic volume | Day of inclusion and one month after inclusion | Remodeling ETT |
| measurement remodeling | One month after inclusion | Remodeling ETT |
| Creatinine level | Day of inclusion and one month after inclusion | Biological outcome |
Countries
France
Outcome results
None listed