title: A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction (REGENERATE-AMI).
abstract: BACKGROUND
  Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide despite the latest therapeutic advances designed to decrease myocardial injury. Preclinical and emerging clinical evidence show that the intracoronary injection of autologous bone marrow mononuclear cells (BMCs) following AMI leads to improvement in left ventricular ejection function (LVEF). In this clinical trial we will for the first time assess the effect of early (<24 h) infusion of autologous BMCs following AMI on cardiac function.
  
  
  METHODS
  REGENERATE-AMI is a double-blind, randomised, multicentre, placebo-controlled trial to determine whether early (<24 h) intracoronary infusion of BMCs improves LVEF after AMI. The study will enrol 100 patients presenting with an anterior AMI demonstrating anterior regional wall motion abnormality. Patients will be randomised to receive intracoronary infusion of BMCs or placebo (0.9% saline). Primary endpoint will be change in LVEF at 1 year compared to baseline, measured by cardiac MRI. Secondary endpoints at 6 months include the change in global LVEF relative to baseline measured by quantitative left ventriculography and echocardiography, as well as major adverse cardiac events which is also measured at 1 year.
  
  
  BACKGROUND
  The study will be performed in agreement with the Declaration of Helsinki and is approved by local ethics committee (NRES Committee London West London: 07/Q0603/76).
  
  
  BACKGROUND
  http://clincialtrials.gov (NCT00765453). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer-reviewed journals.
authors.affiliation: Department of Cardiology, London Chest Hospital, Barts Health NHS Trust, London, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Hamshere
authors.forename: Tawfiq
authors.initials: T
authors.lastname: Choudhury
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Jones
authors.forename: Didier
authors.initials: D
authors.lastname: Locca
authors.forename: Peter
authors.initials: P
authors.lastname: Mills
authors.forename: Martin
authors.initials: M
authors.lastname: Rothman
authors.forename: Charles
authors.initials: C
authors.lastname: Knight
authors.forename: Mahesh
authors.initials: M
authors.lastname: Parmar
authors.forename: Samir
authors.initials: S
authors.lastname: Agrawal
authors.forename: John
authors.initials: J
authors.lastname: Martin
authors.forename: Anthony
authors.initials: A
authors.lastname: Mathur
mesh_terms: D056988:Anterior Wall Myocardial Infarction / Q000628:therapy*; D016026:Bone Marrow Transplantation; D017023:Coronary Angiography; D003952:Diagnostic Imaging; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D012107:Research Design; D014182:Transplantation, Autologous; D016896:Treatment Outcome