Study hypothesis : The purpose of this study is to determine whether Intracoronary infusion of autologous bone marrow derived progenitor cells to patients undergoing primary angioplasty for acute anterior myocardial infarction will lead to an improvement in cardiac function greater than that seen by placebo alone. Aims * To demonstrate that it is safe and feasible to deliver autologous bone marrow derived stem cells within hours of the primary angioplasty procedure * To demonstrate the effects of autologous bone marrow derived stem cells on cardiac function using cardiac MRI (or cardiac CT), echocardiography and left ventriculography. * To demonstrate the effect of autologous bone marrow derived stem cells in addition to standard care leads to improvement in cardiac function compared to patients saline(placebo) and standard care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Over-the-wire balloon catheter delivers infusion into coronary vessel using a stop-flow technique
Placebo infusion
Rigshopitalet, Unversity of Copenhagen
Copenhagen, Denmark
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland
London Chest Hospital, Barts and The London NHS Trust
Bethnal Green, London, United Kingdom
The Heart Hosptial, UCLH Foundation Trust
London, United Kingdom
The Royal Free Hospital, Royal Free London Foundation Trust
London, United Kingdom
Longitudinal change in left ventricular function (ejection fraction)
Time frame: 1 year
Longitudinal change in left ventricular function (ejection fraction), change in left ventricular end systolic volume, and change in infarct size
Time frame: 3 months
Longitudinal change in left ventricular function as measured by LV angiography
Time frame: 6 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time frame: 6 months
Change in left ventricular end systolic volume and change in infarct size.
Time frame: 12 months
Longitudinal change in left ventricular function assessed by echocardiography.
Time frame: 12 months
MACE
Time frame: 12 months
Change in Quality of life
Time frame: 6 and 12 months
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