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Long-term results after intracoronary injection of autologous mononuclear bone marrow cells in acute myocardial infarction : the ASTAMI randomised , controlled study . OBJECTIVE To investigate long-term safety and efficacy after intracoronary injection of autologous mononuclear bone marrow cells ( mBMCs ) in acute myocardial infarction ( AMI ) . DESIGN Randomised , controlled trial . SETTING Two university hospitals in Oslo , Norway . PATIENTS Patients from the Autologous Stem cell Transplantation in Acute Myocardial Infarction ( ASTAMI ) study were re-assessed 3 years after inclusion . INTERVENTIONS 100 patients with anterior wall ST-elevation myocardial infarction treated with acute percutaneous coronary intervention ( PCI ) were randomised to receive intracoronary injection of mBMCs ( n = 50 ) or not ( n = 50 ) . MAIN OUTCOME MEASURES Change in left ventricular ( LV ) ejection fraction ( primary ) . Change in exercise capacity ( peak VO ( 2 ) ) and quality of life ( secondary ) . Infarct size ( additional aim ) , and safety . RESULTS The rates of adverse clinical events in the groups were low and equal . There were no significant differences between groups in change of global LV systolic function by echocardiography or magnetic resonance imaging ( MRI ) during the follow-up . On exercise testing , the mBMC-treated patients had larger improvement in exercise time from 2-3 weeks to 3 years ( 1.5 minutes vs 0.6 minutes , p = 0.05 ) , but the change in peak oxygen consumption did not differ ( 3.0 ml/kg/min vs 3.1 ml/kg/min , p = 0.75 ) . CONCLUSION The results indicate that intracoronary mBMC treatment in AMI is safe in the long term . A small improvement in exercise time in the mBMC group was found , but no other effects of treatment could be identified 3 years after cell therapy .
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Intervention_Pharmacological
intracoronary injection of autologous mononuclear bone marrow cells
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Intervention_Pharmacological
intracoronary injection of autologous mononuclear bone marrow cells ( mBMCs )
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Intervention_Surgical
acute percutaneous coronary intervention ( PCI )
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Intervention_Pharmacological
intracoronary injection of mBMCs
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Intervention_Physical
mBMC-treated
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Intervention_Physical
mBMC
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Outcome_Physical
Change in left ventricular ( LV ) ejection fraction
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Outcome_Physical
Change in exercise capacity ( peak VO ( 2 ) )
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Outcome_Other
quality of life
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Outcome_Physical
Infarct size ( additional aim )
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Outcome_Other
safety
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Outcome_Adverse-effects
rates of adverse clinical events
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Outcome_Physical
change of global LV systolic function
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Outcome_Physical
exercise time
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Outcome_Physical
peak oxygen consumption
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Participant_Condition
acute myocardial infarction :
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Participant_Condition
ASTAMI
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Participant_Condition
acute myocardial infarction ( AMI )
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Participant_Condition
Acute Myocardial Infarction ( ASTAMI )
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Participant_Sample-size
100
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Participant_Condition
ST-elevation myocardial infarction
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Participant_Condition
percutaneous coronary intervention ( PCI )