BACKGROUND: The effects on left ventricular function of intracoronary injection of bone marrow cells in acute myocardial infarction (AMI) have been studied with conflicting results. The aim of this substudy of the ASTAMI trial was to examine the effects of this novel treatment on exercise capacity and quality of life. METHODS: We studied 100 patients with anterior wall ST-elevation AMI. All had percutaneous coronary intervention with stent in the proximal or mid left anterior descending coronary artery 2 to 12 hours after start of symptoms. Patients were randomized to intracoronary injection of mononuclear bone marrow cells (mBMCs) in left anterior descending coronary artery 6 +/- 1.3 days after AMI (n = 50) or control (n = 50). Assessment of physical capacity by maximal symptom-limited bicycle ergometer exercise tests and quality of life by the Short Form 36 health survey was performed 2 to 3 weeks and 6 months after the AMI. RESULTS: There was a significantly greater improvement in exercise time in the mBMC group than in the control group (treatment effect 0.9 minute, 95% CI 0.3-1.6, P < .01), and a similar improvement in peak oxygen consumption in the groups (2.8 +/- 3.9 mL/[kg min] in the mBMC group vs 2.4 +/- 3.5 mL/[kg min] in controls, P = .62). Peak heart rate and percentage of heart rate reserve increased significantly more in the treatment group than in the control group. Treatment with mBMCs did not influence quality of life. CONCLUSIONS: In this randomized open-labeled study, the mBMC group significantly improved exercise time and heart rate responses to exercise compared with the control group. There was no treatment effect on peak oxygen consumption.
RCT Entities:
BACKGROUND: The effects on left ventricular function of intracoronary injection of bone marrow cells in acute myocardial infarction (AMI) have been studied with conflicting results. The aim of this substudy of the ASTAMI trial was to examine the effects of this novel treatment on exercise capacity and quality of life. METHODS: We studied 100 patients with anterior wall ST-elevation AMI. All had percutaneous coronary intervention with stent in the proximal or mid left anterior descending coronary artery 2 to 12 hours after start of symptoms. Patients were randomized to intracoronary injection of mononuclear bone marrow cells (mBMCs) in left anterior descending coronary artery 6 +/- 1.3 days after AMI (n = 50) or control (n = 50). Assessment of physical capacity by maximal symptom-limited bicycle ergometer exercise tests and quality of life by the Short Form 36 health survey was performed 2 to 3 weeks and 6 months after the AMI. RESULTS: There was a significantly greater improvement in exercise time in the mBMC group than in the control group (treatment effect 0.9 minute, 95% CI 0.3-1.6, P < .01), and a similar improvement in peak oxygen consumption in the groups (2.8 +/- 3.9 mL/[kg min] in the mBMC group vs 2.4 +/- 3.5 mL/[kg min] in controls, P = .62). Peak heart rate and percentage of heart rate reserve increased significantly more in the treatment group than in the control group. Treatment with mBMCs did not influence quality of life. CONCLUSIONS: In this randomized open-labeled study, the mBMC group significantly improved exercise time and heart rate responses to exercise compared with the control group. There was no treatment effect on peak oxygen consumption.
Authors: Giuseppe Astori; Sabrina Soncin; Viviana Lo Cicero; Francesco Siclari; Daniel Sürder; Lucia Turchetto; Gianni Soldati; Tiziano Moccetti Journal: Am J Transl Res Date: 2010-05-15 Impact factor: 4.060