Heart Failure Clinical Trial
Official title:
The Impact of Repeated Intracoronary Injection of Autologous Bone-marrow Derived Mononuclear Cells for Left Ventricle Contractility and Remodeling in Patients With STEMI.Prospective Randomized Study.
This is multicentre, randomised open-label, controlled, parallel-group phase III study. Its aim is to demonstrate that a triple intracoronary infusion of autologous bone marrow-derived mononuclear cells in addition to state of the art treatment is safe and reduces all-cause mortality in patients with reduced left ventricular ejection fraction (≤45%) after successful reperfusion for acute myocardial infarction when compared to a control group of patients undergoing best medical care.
The study is divided into 3 parts:
- Screening phase: Patients will be recruited at the investigational clinical centers.
Alternatively, patients who had primary PCI performed at institutions different from the
investigational sites can also be enrolled. Interested patients may be referred for
screening to any of the participating study sites after acute reperfusion therapy.
Informed consent and assessment of eligibility of patients with respect to in- and
exclusion criteria will be done at the investigational site. If all other eligibility
criteria are met, echocardiography will be performed 3 to 6 days after the acute PCI,
and ejection fraction will be quantified by a central Echo Core Lab after web based
transmission. CT examination will be performed 1 month after acute PCI in all screened
patients with LVEF ≤ 45%. If LVEF will not improve ≥5% in the CT the patient may be
qualified into the Study.
- Treatment phase: Bone marrow aspiration will be performed for the patients assigned to
the treatment group (II). Bone marrow will be collected from the patient and MNC
isolated using point-of-care system (Harvest) at a Site. Intracoronary infusion of
BM-MNCs will be performed up to 2 hours after isolation via radial approach. Same
procedure will be performed 3 and 6 months after first application.
- Follow-up phase: After hospital discharge, patients will be followed up per telephone 30
days and 3, 6, 9 months after randomisation and with a site visit with CT examination 12
months after randomisation. Afterwards, telephone follow up will be performed every 3
months. Once the required number of clinical events has been observed, all patients will
attend a final study visit, but minimum follow up period for each patient is 2 years.
Endpoints will be reported as occurring throughout the follow up.
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