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

Antwerp University Hospital (UZA)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Myocardial Infarction

Treatments: Procedure: Intracoronary mononuclear cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT00497211

EC 3/39/123

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)