دورية أكاديمية
Colchicine for Left Ventricular Infarct Size Reduction in Acute Myocardial Infarction: A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Protocol – The COVERT-MI Study
| العنوان: | Colchicine for Left Ventricular Infarct Size Reduction in Acute Myocardial Infarction: A Phase II, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study Protocol – The COVERT-MI Study |
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| المؤلفون: | Bresson, Didier, Roubille, François, Prieur, Cyril, Biere, Loic, Ivanes, Fabrice, Bouleti, Claire, Dubreuil, Olivier, Rioufol, Gilles, Boutitie, Florent, Sideris, Georges, Elbaz, Meyer, Bochaton, Thomas, de Bourguignon, Charles, El Jonhy, Naoual, Dufay, Nathalie, Dhelens, Carole, Croisille, Pierre, Prunier, Fabrice, Angoulvant, Denis, Ovize, Michel, Maucort-Boulch, Delphine, Mewton, Nathan |
| المساهمون: | Centre Hospitalier Emile Muller Mulhouse (CH E.Muller Mulhouse), Groupe Hospitalier de Territoire Haute Alsace (GHTHA), Physiologie & médecine expérimentale du Cœur et des Muscles U 1046 (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Hôpital Louis Pradel CHU - HCL, Hospices Civils de Lyon (HCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon, MitoVasc - Physiopathologie Cardiovasculaire et Mitochondriale (MITOVASC), Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Transplantation, Immunologie, Inflammation Tours (T2i), Université de Tours (UT), CIC Poitiers – Centre d'investigation clinique de Poitiers (CIC 1402), Université de Poitiers = University of Poitiers (UP)-Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie )-Direction Générale de l'Organisation des Soins (DGOS)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre hospitalier universitaire de Poitiers = Poitiers University Hospital (CHU de Poitiers La Milétrie ), Centre d'Investigation Clinique Bron (CIC1407), Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Groupement Hospitalier Est Bron, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Hôpital Lariboisière-Fernand-Widal APHP, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Neurobiotec HCL, Lyon, Hospices Civils de Lyon, Departement de Neurologie (HCL), Hôpital neurologique et neurochirurgical Pierre Wertheimer CHU - HCL, Hôpital Edouard Herriot CHU - HCL, Centre de Recherche en Acquisition et Traitement de l'Image pour la Santé (CREATIS), Université de Lyon-Université de Lyon-Institut National des Sciences Appliquées de Lyon (INSA Lyon), Université de Lyon-Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Université Jean Monnet - Saint-Étienne (UJM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Universitaire de Saint-Etienne CHU Saint-Etienne (CHU ST-E), Service de Biostatistiques Lyon |
| المصدر: | ISSN: 0008-6312. |
| بيانات النشر: | HAL CCSD Karger |
| سنة النشر: | 2021 |
| المجموعة: | Institut National de la Recherche Agronomique: ProdINRA |
| مصطلحات موضوعية: | Acute myocardial infarction, Colchicine, Inflammation, Left ventricular remodeling, Magnetic resonance imaging, ST-segment elevation myocardial infarction, [SDV]Life Sciences [q-bio] |
| الوصف: | International audience ; Inflammatory processes have been identified as key mediators of ischemia-reperfusion injury in ST-segment elevation myocardial infarction (STEMI). They add damage to the myocardium and are associated with clinical adverse events (heart failure and cardiovascular death) and poor myocardial recovery. Colchicine is a well-known alkaloid with potent anti-inflammatory properties. In a proof-of-concept phase II trial, colchicine has been associated with a significant 50% reduction of infarct size (assessed by creatine kinase levels) in comparison to placebo in acute STEMI patients referred for primary percutaneous coronary intervention (PPCI). The Colchicine in STEMI Patients Study (COVERT-MI) is an ongoing confirmative prospective, multicenter, randomized, double-blind trial testing whether a short course oral treatment with colchicine versus placebo decreases myocardial injury in patients presenting with STEMI referred for PPCI. Adult patients, with a first STEMI episode and an initial TIMI flow ≤1, referred for PPCI, will be randomized (n = 194) in a 1:1 ratio to receive an oral bolus of colchicine of 2 mg followed by 0.5 mg b.i.d. treatment during 5 days or matching placebo. The primary endpoint will be the reduction in infarct size as assessed by cardiac magnetic resonance at 5 ± 2 days between both groups. The main secondary endpoints will be tested between groups in hierarchical order with left ventricular ejection fraction at 5 days, microvascular obstruction presence at 5 days, and absolute adverse left ventricular remodeling between 5 days and 3 months. This academic study is being financed by a grant from the French Ministry of Health (PHRCN-16-0357). Results from this study will contribute to a better understanding of the complex pathophysiology underlying myocardial injury after STEMI. The present study describes the rationale, design, and methods of the trial. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | info:eu-repo/semantics/altIdentifier/pmid/33582664; hal-03141339; https://hal.science/hal-03141339Test; https://hal.science/hal-03141339/documentTest; https://hal.science/hal-03141339/file/2021%20Bresson%20et%20al.,%20Colchicine.pdfTest; PUBMED: 33582664 |
| DOI: | 10.1159/000512772 |
| الإتاحة: | https://doi.org/10.1159/000512772Test https://hal.science/hal-03141339Test https://hal.science/hal-03141339/documentTest https://hal.science/hal-03141339/file/2021%20Bresson%20et%20al.,%20Colchicine.pdfTest |
| حقوق: | info:eu-repo/semantics/OpenAccess |
| رقم الانضمام: | edsbas.9BFC42FB |
| قاعدة البيانات: | BASE |
| DOI: | 10.1159/000512772 |
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