Myocardial Infraction Clinical Trial Study to Observe Obstacles in Future Years
Release Date: 19-Nov-2020
Researchers are inclined towards evaluating autologous cell-based therapy for the patients that have acute MI. It has been concluded by the researchers that the therapy could decrease HF hospitalization. But inadequate recruitment for the clinical trial and 75% reduction in mortality led to underpowered trial for concluding the role of autologous cell therapy in the treatment of acute myocardial infarction.
A total of 375 patients were recruited for the clinical trial study. The enrolled patients received intracoronary infusion of bone marrow-derived mononuclear cells into the culprit coronary artery that was treated with primary PCI between 2 and 8 days after the procedure. An important primary endpoint of the clinical trial was time from randomization to all-cause mortality. As per the researchers, it was analyzed that nearly 3,000 patients would be needed to determine a 25% reduction in all-cause mortality. The whole clinical trial that was conducted was a randomized, open label, multicenter, phase 3 outcome trial but later on the whole clinical trial was changed to only estimation study as there were reduced number of enrolled patients. It was concluded by the researchers that due to high success rate of primary angioplasty and medical therapy; the respective clinical trial was not successful. No difference was observed in the control group and the treatment group in any parameter therefore, it was concluded that there could be certain challenges in the future with respect to the conductance of studies for myocardial infection.
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