Intracoronary Infusion of BM-Derived Mononuclear Cells in Patients With Large Acute Myocardial Infarction

Study Overview
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Brief Summary
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Large acute myocardial infarctions are the most frequent cause of subsequent systolic heart failure. Some evidence exists on the improvement after intracoronary administration of bone marrow cells in patients with a recente acute myocardial infarction. Although subgroup analyses suggest that patients with the largest myocardial infarctions have the largest increase in ejection fraction after intracoronary bone marrow administration, there is no published trial including only large myocardial infarctions. Therefor we sought to confirm the subgroup analyses by conducting a trial in only large first acute myocardial infarction patients.

Conditions
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Myocardial Infarction

Intervention / Treatment
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* Procedure: Intracoronary mononuclear cell infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥20 and <80 years old Acute myocardial infarction >2 and <96 hours from start to reperfusion Cumulative ST-segment elevation >6 mm on 12 lead ECG No functional myocardial impairment outside the myocardial infarction region Succesful PCI of infarct related coronary artery Left ventricular ejection fraction <50% on ventriculography, echo or MRI Accepted anticonceptive use during the study for women of childbearing potential Written and signed informed consent Exclusion Criteria: CPR > 10 minuts or persistent cardiogenic shock complete left bundle branch block without concordant ST-segment elevation Need foor cardiac surgery (valvular, coronary or other) Trombocytopenia, coagulation disorders or hematological disease History or active malignancy Life expectancy (apart from acute myocardial infarction) <5 years Dialysis or severe kidney insufficiency (creatinin clearance <30ml/') Severe liver insufficiency Severe respiratory disease Systemic inflammatory pathology (acute or chronic, apart from inflammation associated with myocardial infarction) Symptomatic cerebral or periferal vascular disease Prior myocardial infarction or prior myocardial dysfunction Prior CABG or heart valve surgery Pregnancy, pregnancy wish or lactation <1 month Psychiatrical illness Physical or psychological inability to adhere to the protocol Participation in other not yet completed study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intracoronary mononuclear cell infusion|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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First large acute myocardial infarction