Titre
A randomized double-blind control study of early intra-coronary autologous bone marrow cell infusion in acute myocardial infarction: the REGENERATE-AMI clinical trial†.
Type
article
Institution
UNIL/CHUV/Unisanté + institutions partenaires
Périodique
Auteur(s)
Choudry, F.
Auteure/Auteur
Hamshere, S.
Auteure/Auteur
Saunders, N.
Auteure/Auteur
Veerapen, J.
Auteure/Auteur
Bavnbek, K.
Auteure/Auteur
Knight, C.
Auteure/Auteur
Pellerin, D.
Auteure/Auteur
Locca, D.
Auteure/Auteur
Westwood, M.
Auteure/Auteur
Rakhit, R.
Auteure/Auteur
Crake, T.
Auteure/Auteur
Kastrup, J.
Auteure/Auteur
Parmar, M.
Auteure/Auteur
Agrawal, S.
Auteure/Auteur
Jones, D.
Auteure/Auteur
Martin, J.
Auteure/Auteur
Mathur, A.
Auteure/Auteur
Liens vers les personnes
Liens vers les unités
ISSN
1522-9645
Statut éditorial
Publié
Date de publication
2016-01-14
Volume
37
Numéro
3
Première page
256
Dernière page/numéro d’article
263
Peer-reviewed
Oui
Langue
anglais
Notes
Publication types: Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
Publication Status: ppublish
Publication Status: ppublish
Résumé
Clinical trials suggest that intracoronary delivery of autologous bone marrow-derived cells (BMCs) 1-7 days post-acute myocardial infarction (AMI) may improve left ventricular (LV) function. Earlier time points have not been evaluated. We sought to determine the effect of intracoronary autologous BMC on LV function when delivered within 24 h of successful reperfusion therapy.
A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups.
The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage.
A multi-centre phase II randomized, double-blind, and placebo-controlled trial. One hundred patients with anterior AMI and significant regional wall motion abnormality were randomized to receive either intracoronary infusion of BMC or placebo (1:1) within 24 h of successful primary percutaneous intervention (PPCI). The primary endpoint was the change in left ventricular ejection fraction (LVEF) between baseline and 1 year as determined by advanced cardiac imaging. At 1 year, although LVEF increased compared with baseline in both groups, the between-group difference favouring BMC was small (2.2%; 95% confidence interval, CI: -0.5 to 5.0; P = 0.10). However, there was a significantly greater myocardial salvage index in the BMC-treated group compared with placebo (0.1%; 95% CI: 0.0-0.20; P = 0.048). Major adverse events were rare in both treatment groups.
The early infusion of intracoronary BMC following PPCI for patients with AMI and regional wall motion abnormality leads to a small non-significant improvement in LVEF when compared with placebo; however, it may play an important role in infarct remodelling and myocardial salvage.
Sujets
PID Serval
serval:BIB_71679DE7920E
PMID
Open Access
Oui
Date de création
2016-03-22T14:49:16.651Z
Date de création dans IRIS
2025-05-21T04:12:45Z
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Nom
BIB_71679DE7920E.P001.pdf
Version du manuscrit
preprint
Taille
325.39 KB
Format
Adobe PDF
PID Serval
serval:BIB_71679DE7920E.P001
URN
urn:nbn:ch:serval-BIB_71679DE7920E7
Somme de contrôle
(MD5):e319830150740c5709e3493a8b6dd48d