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A randomised double-blind control study of early intracoronary autologous bone marrow cell infusion in acute myocardial infarction ( REGENERATE-AMI ) . INTRODUCTION 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 AND ANALYSIS 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 . ETHICS AND DISSEMINATION 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 ) . TRIAL REGISTRATION 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 .
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Intervention_Physical
intracoronary autologous bone marrow cell infusion
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Intervention_Physical
autologous bone marrow mononuclear cells
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Intervention_Control
placebo-controlled
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Intervention_Physical
intracoronary infusion of BMCs
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Intervention_Control
placebo
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Intervention_Pharmacological
saline
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Outcome_Other
effect
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Outcome_Physical
change in LVEF at 1 year compared to baseline
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Outcome_Physical
measured by cardiac MRI
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Outcome_Physical
change in global LVEF relative to baseline measured by quantitative left ventriculography and echocardiography
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Outcome_Adverse-effects
major adverse cardiac events
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Participant_Condition
acute myocardial infarction
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Participant_Sample-size
100 patients
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Participant_Condition
AMI