COLchicine to Prevent Sympathetic Denervation After an Acute Myocardial Infarction
Palavras-chave
Resumo
Descrição
COLD-MI study aims to explore colchicine's impact on myocardial denervation following reperfused acute myocardial infarction. Acute myocardial infarction is the leading cause of heart failure (HF). It induces myocardial denervation predisposing to ventricular rhythm disorders and death. This denervation linked to infarction's size occurs by direct ischaemic mechanisms during the initial coronary occlusion (initially non-vascularised zone) and secondarily by cardiac remodelling in the context of the heart failure (HF). In usual practice, cardiac denervation which intensity is correlated with rhythm and mortality risks, can be evaluated by scintigraphy. In a murine reperfusion model of ischemia, the direct anti-inflammatory effect of colchicine reduces the size of the necrosis and improves post-ischemic remodeling. This suggests that colchicine may reduce myocardial denervation.
datas
| Última verificação: | 05/31/2020 |
| Enviado pela primeira vez: | 04/28/2020 |
| Inscrição estimada enviada: | 06/04/2020 |
| Postado pela primeira vez: | 06/08/2020 |
| Última atualização enviada: | 06/04/2020 |
| Última atualização postada: | 06/08/2020 |
| Data real de início do estudo: | 08/31/2020 |
| Data Estimada de Conclusão Primária: | 08/31/2021 |
| Data Estimada de Conclusão do Estudo: | 08/31/2021 |
Condição ou doença
Intervenção / tratamento
Drug: Colchicine
Fase
Grupos de Armas
| Braço | Intervenção / tratamento |
|---|---|
| Experimental: Colchicine colchicine and standard therapy | Drug: Colchicine 1 mg (or 0.5mg) tablet of colchicine taken once a day for 1 month |
| No Intervention: Comparator standard therapy |
Critério de eleição
| Idades qualificadas para estudar | 18 Years Para 18 Years |
| Sexos elegíveis para estudo | All |
| Aceita Voluntários Saudáveis | sim |
| Critério | Inclusion Criteria: - Age from 18 to 80 year old - Hospitalization within 12 hours of onset of acute chest pain - Patient must have suffered a documented acute myocardial infarction - Coronary occlusion on initial angiography (culprit artery with aTIMI (Thrombolysis in Myocardial Infarction) flow 1 or 0) - Patient eligible for a revascularization procedure by PTCA (Percutaneous transluminal coronary angioplasty) Exclusion Criteria: - Patients with a history of myocardial infarction prior to the current episode - Patient in cardiogenic shock or with hemodynamic instability - Patients with severe hepatic or renal dysfunction (GFR ≤30 mL/min) - Pregnant women or women of childbearing age without contraception - Treatment with a potent CYP3A4 inhibitor or a P-glycoprotein inhibitor in patients with renal or hepatic impairment or an HMGCoA reductase inhibitor - Association with macrolides (except spiramycin) - Association with pristinamycin |
Resultado
Medidas de Resultado Primário
1. Percentage of myocardial denervation [6 month]
Medidas de Resultado Secundário
1. Change in the heart-to-mediastinum ratio [6 month]
2. Left Ventricular Ejection Fraction in percent [6 month]
3. Left Ventricular Ejection Fraction in percent [6 month]
4. Left Ventricular Ejection Fraction in percent [1 month]
5. Change in Sinus variability [6 month]
6. Change in Sinus variability [1 month]
7. Basic ECG parameters (QRS duration) [6 month]
8. Basic ECG parameters (QRS duration) [1 month]
9. Basic ECG parameters (corrected QT) [1 month]
10. Basic ECG parameters (corrected QT) [6 month]
11. Number of ventricular extrasystole (2 or 3 VES) per 24 hours on the Holter [6 month]
12. Number of bursts (2 or 3 VES) per 24 hours on the Holter [1 month]
13. Number of bursts (2 or 3 VES) per 24 hours on the Holter [6 month]
14. Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours [1 month]
15. Number of ventricular or supraventricular tachycardia (>3 VES) episodes per 24 hours [6 month]
16. Time from randomization to death (total mortality) [6 month]
17. Time from randomization to heart failure hospitalization [6 month]
18. Time from randomization to all-cause hospitalization [6 month]
19. Variations in the levels of neurotrophic molecular markers [Between hospitalization and 1 month]
20. Variations in the levels of neurotrophic molecular markers [Between 1 month and 6 months]
21. Variations in the levels of neurotrophic molecular markers [Between hospitalization and 1 month]
22. Variations in the levels of neurotrophic molecular markers [Between 1 month and 6 months]
23. Variations in the levels of neurotrophic molecular markers [Between hospitalization and 1 month]
24. Variations in the levels of neurotrophic molecular markers [Between 1 month and 6 months]
25. Biological evaluation of infarction size Creatine PhosphoKinase (CPK) [During hospitalization (Day 1 to Day 5)]
26. Biological evaluation of infarction size (troponin) [During hospitalization (Day 1 to Day 5)]
27. Post infarction systemic inflammation evaluation [Between hospitalization and 1 month]
28. Post infarction systemic inflammation evaluation [Between 1 month and 6 months]
29. Post infarction systemic inflammation evaluation [Between hospitalization and 1 month]
30. Post infarction systemic inflammation evaluation [Between 1 month and 6 months]
31. Infarct size in percentage of left ventricular [6 month]
32. Number of Adverse event [from randomization to 6 months]
